EP4251047A1 - Dispositifs, systèmes et procédés de prélèvement sanguin - Google Patents

Dispositifs, systèmes et procédés de prélèvement sanguin

Info

Publication number
EP4251047A1
EP4251047A1 EP21899151.1A EP21899151A EP4251047A1 EP 4251047 A1 EP4251047 A1 EP 4251047A1 EP 21899151 A EP21899151 A EP 21899151A EP 4251047 A1 EP4251047 A1 EP 4251047A1
Authority
EP
European Patent Office
Prior art keywords
cannula
access system
tube
catheter
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21899151.1A
Other languages
German (de)
English (en)
Other versions
EP4251047A4 (fr
Inventor
Kevin Jerry COOK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Avia Vascular LLC
Original Assignee
Avia Vascular LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Avia Vascular LLC filed Critical Avia Vascular LLC
Publication of EP4251047A1 publication Critical patent/EP4251047A1/fr
Publication of EP4251047A4 publication Critical patent/EP4251047A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/15074—Needle sets comprising wings, e.g. butterfly type, for ease of handling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0637—Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0693—Flashback chambers

Definitions

  • Certain embodiments described herein relate generally to devices, systems, and methods for blood collection and further embodiments relate more particularly to devices, systems, and methods for facilitating blood collection via a previously placed catheter, such as, for example, a peripheral intravenous catheter.
  • FIG. 1A is a schematic cross-sectional view of a proximal portion of an embodiment of a base catheter system placed within a patient;
  • FIG. 1 B is a schematic cross-sectional view of a distal end of the base catheter system of FIG. 1 A within a blood vessel of a patient;
  • FIG. 2 is a perspective view of an embodiment of an access system configured to be coupled with an embodiment of a base catheter system, the access system being shown in an undeployed or retracted state;
  • FIG. 3 is a side elevation view of the access system of FIG. 2 in the undeployed or retracted state;
  • FIG. 4 is another side elevation view of the access system of FIG. 2 in a fully deployed or advanced state;
  • FIG. 6 is a side elevation view of an embodiment of a cannula compatible with the access system of FIG. 2;
  • FIG. 7 is a side elevation view of a distal portion of the access system of FIG. 2 in the undeployed or retracted state;
  • FIG. 8 is a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;
  • FIG. 9 is a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;
  • FIG. 10 a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;
  • FIG. 11 a cross-sectional view of a distal portion of another embodiment of an access system shown in an undeployed or retracted state;
  • FIG. 12 is a perspective view of an embodiment of a closed intravenous catheter system in a fully assembled state that may be referred to as an insertion configuration;
  • FIG. 13 is a perspective view of the closed intravenous catheter system of FIG. 12 in a state in which a piercing implement has been removed from a hub and catheter tube, which state may be referred to as an access configuration;
  • FIG. 14 is a cross-sectional view of a portion of the closed catheter system of FIG. 12 in the access configuration
  • FIG. 15 is a perspective view of another embodiment of an access system configured to be coupled with embodiments of a base catheter system, the access system being shown in an undeployed or retracted state;
  • FIG. 16 is a cross-sectional view of the access system of FIG. 15 in the undeployed or retracted state
  • FIG. 17A is a perspective view of an embodiment of a housing that is compatible with the access system of FIG. 15;
  • FIG. 170 is another cross-sectional view of the housing of FIG. 17A;
  • FIG. 18A is a perspective view of an embodiment of a coupling member that is compatible with the access system of FIG. 15;
  • FIG. 18B is a cross-sectional view of the coupling member of FIG. 18A;
  • FIG. 19A is a perspective view of an embodiment of a follower that is compatible with the access system of FIG. 15;
  • FIG. 19B is another perspective view of the follower of FIG. 19A;
  • FIG. 19C is a cross-sectional view of the follower of FIG. 19A;
  • FIG. 20 is a cross-sectional view of an embodiment of a connector that is compatible with the access system of FIG. 15;
  • FIG. 21 is a partially exploded elevation view of an embodiment of a cannula showing a tie layer separated from a two-component portion of the cannula that the tie layer is used to connect together;
  • FIG. 22 is an enlarged cross-sectional view of the cannula with the tie layer in place over the two-component portion of the cannula;
  • FIG. 23A is a cross-sectional view of a generally proximal portion of the access system of FIG. 15 in a retracted state
  • FIG. 23B is a cross-sectional view of a distal portion of the access system of FIG. 15 in the retracted state
  • FIG. 24 is an exploded perspective view of an embodiment of a base catheter assembly that includes an embodiment of an open intravenous catheter assembly and an embodiment of an extension set that is couplable to the open intravenous catheter assembly;
  • FIG. 25 is a cross-sectional view of the base catheter assembly of FIG. 24 in an assembled state
  • FIG. 29A Is a cross-sectional view of a generally intermediate portion of the access system while in the configuration depicted in FIG. 28;
  • FIG. 29B is a cross-sectional view of a generally distal portion of the access system of FIG. 15 and a proximal portion of the assembled base catheter assembly of FIG. 25 while in the configuration depicted in FIG. 28;
  • FIG. 290 is a cross-sectional view of distal ends of the access system of FIG. 15 and the assembled base catheter assembly of FIG. 25 while in the configuration depicted in FIG. 28;
  • FIG. 31 is a cross-sectional view of the access system of FIG. 30;
  • FIG. 32A is a perspective view of an embodiment of a coupling member that is compatible with the access system of FIG. 30;
  • FIG. 33 is a cross-sectional view of a distal end of the access system of
  • FIG. 34 is a cross-sectional view of the distal end of the access system of FIG. 30, while in the retracted or undeployed state, coupled with the closed intravenous catheter system;
  • FIG. 35 is a perspective view of another embodiment of an access system configured to be coupled with embodiments of a base catheter system, with the access system being shown in a retracted or undeployed state;
  • FIG. 36 is a cross-sectional view of the access system of FIG. 35 in the retracted state
  • FIG. 37A is a perspective view of an embodiment of a housing that is compatible with the access system of FIG. 35;
  • FIG. 37B is a perspective cross-sectional view of the housing of FIG. 37A;
  • FIG. 38A is a perspective view of an embodiment of a follower that is compatible with the access system of FIG. 35, the follower including a selective engagement feature;
  • FIG. 38B is a cross-sectional view of the follower of FIG. 38A;
  • FIG. 39A is a perspective view of an embodiment of a reinforcing tube assembly that includes a reinforcing tube and a catch;
  • FIG. 39B is a cross-sectional view of the reinforcing tube assembly of FIG.
  • FIG. 40 is a cross-sectional view of a distal end of the access system of FIG. 35 when in the retracted state of FIGS. 35 and 36;
  • FIG. 41 is a cross-sectional view of a distal region of the access system of FIG. 35 when in the retracted state;
  • FIG. 42 is a cross-sectional view of an intermediate region of the access system of FIG. 35 when in the retracted state;
  • FIG. 43 is a cross-sectional view of a generally proximal portion of the access system of FIG. 35 when in the retracted state;
  • FIG. 45 is a cross-sectional view of a generally intermediate region of the access system of FIG. 35 while in the retracted configuration depicted in FIG. 44;
  • FIG. 46 is a cross-sectional view of a distal portion of the access system of FIG. 35 and a proximal portion of the catheter assembly while the access system is in the retracted configuration depicted in FIG. 44;
  • FIG. 47 is a cross-sectional view of the access system of FIG. 35 coupled with the base catheter assembly while in a partially deployed state, or stated otherwise, while in an intermediate stage of deployment;
  • FIG. 49 is a cross-sectional view of a distal end of the access system of FIG. 35 and a proximal portion of the base catheter assembly while the access system is in the intermediate deployment configuration depicted in FIG. 47;
  • FIG. 50 is a cross-sectional view of the access system of FIG. 35 coupled with the base catheter assembly while in a fully deployed state;
  • FIG. 51 is a cross-sectional view of an intermediate region of the access system of FIG. 35 while in the fully deployed state depicted in FIG. 50;
  • FIG. 52 is a cross-sectional view of a generally distal portion of the access system of FIG. 35 and a proximal portion of the base catheter assembly while the access system is in the fully deployed state depicted in FIG. 50;
  • FIG. 53 is a cross-sectional view of distal ends of the access system of FIG. 35 and of the base catheter assembly while the access system is in the fully deployed state depicted in FIG. 50;
  • FIG. 54 is a perspective view of another embodiment of an access system in a retracted state
  • FIG. 55 is a cross-sectional view of the access system of FIG. 54 in the retracted state
  • FIG. 56B is an enlarged cross-sectional view of a proximal region of the access system of FIG. 54 in the retracted state;
  • FIG. 57 is a perspective view of another embodiment of an access system in a retracted state
  • FIG. 58 is a cross-sectional view of the access system of FIG. 57;
  • FIG. 59 is an enlarged cross-sectional view of the access system of FIG.
  • FIG. 57 taken along the view line 59 in FIG. 58 in which an embodiment of a sealing member positioned at a proximal end of a reinforcement tube is shown;
  • FIG. 60 is a cross-sectional view of another embodiment of a sealing member compatible with the access system of FIG. 57;
  • FIG. 62 is a cross-sectional view of the access system of FIG. 61 in the retracted state
  • FIG. 63 is a perspective cross-sectional view of another embodiment of an access system.
  • FIG. 64 is a cross-sectional view of a generally distal portion of the access system of FIG. 63.
  • Embodiments of the present disclosure relate generally to devices, systems, and methods for blood collection (also referred to as blood draws, blood aspiration, phlebotomy procedures, etc.)
  • the blood collection can be achieved via an access system that includes a conduit or cannula that is inserted into a previously placed catheter, such as a catheter tube of a previously placed catheter, such as, for example, a previously placed peripheral intravenous (PIV) catheter.
  • the access system can provide a desirable alternative to venipuncture.
  • fluid particularly blood
  • venipuncture is a method that involves inserting a needle through the skin and into an underlying vein to provide access to the patient’s blood.
  • blood can be drawn as frequently as every six hours.
  • patients can be subjected to multiple attempts each time a needle is inserted into the skin, and the more frequent the withdrawals become, the more difficult it can become to find a location for the next withdrawal. Each attempt can be painful and a nuisance.
  • Difficult intravenous access (DIVA) is a common problem that affects numerous patients.
  • PICC lines peripherally inserted central catheters
  • central lines central lines
  • repeated peripheral venipuncture and groin sticks.
  • this quality reduction may be due to the lumen defined by the catheter becoming more tortuous or otherwise changing shape as the catheter softens.
  • the catheter may have relatively few curves and/or regions of the catheter that extend through the skin and the vessel wall may define a rounded cross-sectional profile.
  • the softening or softened catheter may become compliant so as to conform to tortuous anatomy through which it passes and/or the cross-sectional profile at the insertion regions may flatten or otherwise change shape. Blood drawn through these altered regions may, for example, be more susceptible to hemolysis.
  • conduit or cannula through a previously placed catheter (e.g., a PIV catheter) to achieve a high-quality blood draw through the catheter.
  • catheter e.g., a PIV catheter
  • the cannula can have sufficient rigidity to provide or maintain a patent lumen through which blood can readily pass.
  • the cannula can be readily inserted through tortuous path into and/or through a blood vessel.
  • the distal end of the cannula may be placed distally relative to the tip of the previously placed catheter, which may, for example, avoid interference from clots or fibrin sheaths; permit access to a region beyond an otherwise obstructing anatomical feature, such as by moving past one or more venous valves and/or away from a vessel wall: permit movement to a region of increased blood flow; and/or move away from a region of vascular trauma due to venipuncture and catheter insertion, any or all of which can result in substantially improved blood draws, such as, for example, by establishing blood flow and/or by reducing hemolysis of the sampled blood.
  • a catheter is introduced into a patient, and subsequently, a cannula is introduced into the patient through the catheter.
  • the catheter may be referred to herein as a placed catheter, a preplaced catheter, an anchor catheter, or a base catheter.
  • the cannula may, in some instances, also be referred to as a conduit, a fluid channeler, a fluid extraction member, etc.
  • the cannula will have properties different from the placed catheter. For example, in some instances, at least a portion of the cannula may be stiffer or more rigid than the placed catheter.
  • the cannula may, in some instances, define an open lumen or passageway through which blood can pass from the vessel and out of the patient through the cannula into any suitable blood collection device.
  • the cannula may, in some instances, be reinforced so as to avoid buckling or kinking in order to readily enter and extend through a tortuous path of a lumen defined by the catheter.
  • the cannula may straighten or otherwise reduce a tortuousness of a path through a preplaced catheter system.
  • the cannula may be advanced past a distal end of the placed catheter.
  • FIGS. 1A and 1 B depict an embodiment of a base catheter system 100, such as, for example, a peripheral intravenous (PIV) catheter system.
  • the base catheter system 100 may also be referred to herein as a placed catheter system, a preplaced catheter system, an anchor catheter system, etc.
  • the base catheter system 100 includes a catheter tube 104 and a catheter hub 106 that is fixedly secured to a proximal end of the catheter tube 104.
  • the base catheter system 100 can be inserted into a patient P in any suitable manner such that at least a distal end of the catheter tube 104 extends into a vessel V (e.g., a vein) of the patient (FIG.
  • V e.g., a vein
  • the catheter tube 104 can define a lumen 108 through which, for example, infusions may be delivered into the vessel V.
  • the catheter hub 106 may be of any suitable variety. In some embodiments, the catheter hub 106 is a female luer connector.
  • the proximal portion of the base catheter system 100 that remains at an exterior of the patient P after placement of the catheter tube 104 can be secured to the skin of the patient.
  • a variety of dressing options are possible, including tape or adhesive dressings that are specifically designed for such securement.
  • the base catheter system 100 can be an open catheter system, such as an open intravenous catheter system (e.g., an open PIV catheter system).
  • an open catheter system such as an open intravenous catheter system (e.g., an open PIV catheter system).
  • the term “open” in this context is used in its ordinary sense in the relevant art, and includes catheter systems in which the connector 106 may not provide a barrier (e.g., a fluid-tight seal) between the lumen 108 and the environment external to the catheter hub 106.
  • the catheter hub 106 defines an open proximal end that is exposed to the environment.
  • a sealing member such as any suitable valve, septum, or needleless connector, may be affixed to the catheter hub 106.
  • an extension set may be coupled with the catheter hub 106.
  • the extension set can include a connector at a proximal end thereof, a connector at a distal end thereof for coupling with the catheter hub 106, and a sideport therebetween with an extension tube and any suitable connector at a proximal end of the extension tube.
  • the proximal connector may include or be coupled with a valve, septum, or needleless connector.
  • the base catheter system 100 may instead be a “closed” catheter system, such as a closed intravenous catheter system (e.g., a closed PIV catheter system).
  • a closed intravenous catheter system e.g., a closed PIV catheter system
  • FIGS. 12-14 An illustrative example of such a closed intravenous catheter system is depicted in, and discussed further below, with respect to FIGS. 12-14.
  • closed in this context is used in its ordinary sense in the relevant art, and includes systems in which the catheter tube 104 is attached to a distal port of a catheter hub 106 that further includes a proximal port, from which an introducer needle can be withdrawn and thereupon sealed or plugged, and an integrated side port in fluid communication with the catheter tube 104, via which fluid delivery and/or removal via the catheter tube 104 is achieved.
  • a closed PIV catheter system is the NEXIVATM closed IV catheter system, available from Becton Dickinson.
  • an access system 200 can be configured to couple with the base catheter system 100.
  • the access system 200 may also or alternatively be referred to as an access assembly.
  • the illustrated access system 200 may be particularly well suited for coupling with and/or for operative use in advancing a conduit into an open base catheter system 100, such as the illustrative system 100 depicted in FIGS. 1 and 2.
  • the access system 200 can be configured to couple with an extension set (e.g., such as that depicted in FIG. 24) of an open base catheter system 100, and can advance a conduit through the extension set and ultimately into the catheter tube 104.
  • the access system 200 can also be referred to as a fluid channeling system, a fluid extraction system, a blood removal system, a follow-on cannula system, a secondary catheter system, a supplemental catheter system, etc.
  • the base catheter system 100 such as the catheter tube 104 thereof, can be inserted into a vessel of a patient in any suitable manner, including those known in the art.
  • no portion of the access system 200 is coupled with the base catheter system 100 prior to insertion of the base catheter system 100 into the patient.
  • the access system 200 may be coupled with the base catheter system 100 after the base catheter system 100 has been placed within the patient.
  • one or more portions of the access system 200 may be coupled to the base catheter system 100 at any suitable time after placement of the base catheter system 100.
  • the suitable time may be no less than 30 minutes, 1 hour, 6 hours, 12 hours, 18 hours, 1 day, 2 days, or 3 days after initial placement of the base catheter system 100.
  • the access system 200 includes a connector 202 and a cannula 204.
  • the cannula 204 may also be referred to as a conduit.
  • the cannula 204 can define a continuous fluid path through which blood can be extracted from the vasculature of a patient.
  • the cannula 204 is configured to move relative to the connector 202 between a retracted or undeployed state (FIGS. 2 and 3) and an advanced or deployed state (FIGS. 4 and 5).
  • a user can grip the cannula 204 — e.g., a proximal end of the cannula 204 — to distally advance (e.g., translate forwardly) the cannula 204 relative to the connector 202 from the retracted state to the advanced state.
  • the user can grip the cannula 204 — e.g., the proximal end of the cannula 204 — to retract proximally (e.g., translate rearwardly) the cannula 204 relative to the connector 202 from the advanced state back to the retracted state.
  • the user can grip a connector 229 at a proximal end of the cannula 204 to advance and/or retract the cannula 204.
  • the connector 202 may be longitudinally elongated so as to be substantially tubular in shape.
  • a distal end of the connector 202 may include a connection region 203 at a distal end thereof that defines the coupling interface 210, and can further include a housing, barrel, tube, or sheath 205 that extends proximally from the connection region 203.
  • the sheath 205 can define an extended channel 212 (FIG. 5), which may also be referred to as an inner chamber, cavity, or interior space, within which a portion of the cannula 204 may be positioned.
  • At least some portion of the cannula 204 may be positioned within or internal to the sheath 205 when the cannula 204 is in the retracted state, the deployed state, and throughout transitioning between the retracted and deployed states.
  • the cannula 204 can be a multi-part or multi-segment component.
  • the cannula 204 is a three-segment element that defines a continuous or uninterrupted flow path or fluid path 220 for blood draws.
  • each segment is defined by a separate piece, with each piece being formed of one or more materials that are different from materials of one or more of the other two pieces.
  • two or more of the multiple segments e.g., the proximal and medial segments
  • each segment may include one or multiple components or constituent elements.
  • the cannula 204 can include a proximal segment 222, a middle, intermediate, or medial segment 224, and a distal segment 226, as identified in FIG. 6.
  • the materials and/or material properties of at least one of the segments can vary relative to that or those of one or more of the remaining segments.
  • the connector 229 can be configured to couple with a syringe, which may be used for infusion or blood collection.
  • the connector 229 may be used for connection to blood draw apparatus, such as syringes or evacuated blood collection tubes (e.g., Vacutainer® tubes available from Becton Dickinson) and/or apparatus therefor.
  • the connector 229 may include or may be configured to connect with a Vacutainer® one-use holder, via which blood draws may be made into one or more Vacutainer® tubes.
  • the connector 229 may be integrally formed with a fluid source and/or a fluid collection apparatus.
  • a valve or vent fitting may be removably attached to or incorporated into the proximal segment 222.
  • a vent fitting (such as, e.g., the vent fitting 819 depicted in FIG. 12) can, for example, permit blood flow from the vasculature through the cannula 204 as air within the cannula lumen 221 is vented to the environment, and the vent fitting can serve as a liquid-impervious barrier to the blood, in some embodiments, the proximal segment 222 can allow visualization of an initial passage of blood through the lumen 221 , or stated otherwise, can provide blood flashback visualization.
  • the proximal segment 222 when the proximal segment 222 includes a tube of clear or translucent material, the proximal segment 222 can allow for potential visualization of blood flashback.
  • the proximal segment 222 can include or be formed of a tube of polycarbonate, polyurethane, and/or polypropylene. Any other or further suitable material is contemplated.
  • the proximal segment 222 may be relatively rigid.
  • the proximal segment 222 may have a rectilinear configuration, such as depicted in FIG. 6, and may be relatively resistant to lateral deformation from the rectilinear shape.
  • the proximal segment 222 may be preformed, packaged, and usable in the rectilinear shape, and in further embodiments, may be substantially resistant to deformations from the rectilinear shape.
  • the medial segment 224 of the cannula 204 can be stiff or rigid so as to avoid bending or kinking.
  • the medial segment 224 can transfer distal forces from the proximal segment 222 to the distal segment 226.
  • the medial segment 224 may include or be formed of metal, such as, for example, stainless steei.
  • the medial segment 224 consists substantially of a metallic tube, such as a hypotube, that is coupled to the distal segment 226.
  • the medial segment includes a metallic tube, such as a hypotube, that encompasses a portion of a polymeric tube that extends through a lumen of the metallic tube.
  • Other or further suitable materials and/or configurations are also contemplated.
  • the proximal segment 222 and the medial segment 224 may be joined together in any suitable manner.
  • the proximal segment 222 may be overmolded over a proximal end of the medial segment 224.
  • the proximal and medial segments 222, 224 may be press-fit, friction-fit, adhered, or otherwise joined together, and may be fluidically sealed such that no leakage from the lumen 221 occurs at the interface between these two segments.
  • the distal segment 226 may be relatively soft or flexible so as to readily advance through the preplaced catheter 104.
  • the distal segment 226 can be substantially softer and/or more flexible (e.g., can be laterally deflected much easier) than the medial segment 224.
  • the distal segment 226 may be sufficiently soft or flexible to prevent or inhibit damage to the catheter tube 104 and/or, in certain embodiments, the blood vessel V (e.g., should the distal segment 226 be extended past the distal end of the catheter tube 104 and come into contact with the blood vessel V).
  • the distal segment 226 may be sufficiently rigid to be advanced through the catheter tube 104.
  • the distal segment 226 may render the catheter tube 104 straighter as the distal segment 226 is advanced therethrough.
  • the distal segment 226 may be fully positioned within the catheter tube 104 when the cannula 204 is in the advanced state, such that the distal tip 227 is proximally recessed or generally flush with a distal tip of the catheter tube 104, or the distal segment 226 may extend slightly beyond the distal tip of the catheter tube 104, during a blood draw.
  • the distal segment 226 can conform to a tortuous path of the vasculature and/or defined by the preplaced catheter system 100 when a portion of the catheter system 100 (I. e., at least a portion of the catheter tube 104) is positioned within the vasculature.
  • the distal segment 226 can prevent damage to the catheter tube 104, e.g., during advancement therethrough.
  • the distal segment 226 can include or be formed of polyimide, polyether block amide, silicone, polyamide, nylon, PEEK, and/or polyurethane.
  • the distal segment can comprise a siliconized polyurethane, such as one or more of the materials described in U.S. Patent Application Publication No. 2019/0153147 to Muse et al., the entire contents of which are hereby incorporated by reference herein. Any other or further suitable material is also contemplated.
  • the distal segment 226 can have sufficient rigidity to at least partially straighten out the catheter tube 104 of the system 100 as the distal segment 226 is advanced through the catheter tube 104.
  • the distal segment 226 can have a stiffness that is greater than the stiffness of the catheter tube 104. Straightening via the distal segment may, in some instances, facilitate blood withdrawal and/or permit laminar or substantially laminar blood flow through the cannula 204. Stated otherwise, the distal segment 226 can provide a straight or straightened flow path, relative to a flow path that is defined by the preplaced catheter system 100 prior to use of the system 200.
  • the fluid path 220 through the deployed system 200 can be substantially straight or rectilinear, or can be gently sloped or gradually bent (e.g., without sharp turns or kinking) along the length of at least the distal segment 226 when the system 200 is deployed within the preplaced catheter system 100.
  • the distal segment 226, or at least a distal portion thereof, can be sized to slide or otherwise be advanced through the lumen 108 of the catheter tube 104.
  • the distal segment 226 may be relatively softer than embodiments that might achieve significant straightening of a pre-placed catheter tube. In various embodiments, the distal segment may achieve a lower amount, a minimal amount, or even substantially no straightening of the preplaced catheter tube 104. A relatively softer distal segment 226 may nevertheless be able to follow a tortuous path through the catheter system 100 while maintaining patency of the lumen 221 therethrough. In some embodiments, lateral support provided to the distal segment 226 by a reinforcement member Included in the connector 202 and/or strength and kink-resistance afforded by the medial segment 224 can assist in advancing the distal segment 226 into the catheter tube 104, as further discussed below.
  • the distal segment 226 may be joined with the medial segment 224 in any suitable manner.
  • the medial segment 224 and the distal segment 226 are attached via a length of thin-walled heat shrink tubing (see, e.g., FIGS. 21 and 22).
  • Such an attachment mechanism may be particularly useful, e.g., when the medial segment 224 includes a metal (e.g., stainless steel) tube and the distal segment 226 includes a polymeric tube that abuts the metal tube. Any other or further suitable attachment is contemplated.
  • only the distal segment 226 is introduced into and passes through the preplaced catheter tube 104. Stated otherwise, when the access system 200 is in a fully deployed state, the distal end of the medial segment 224 remains proximal to the proximal end of the catheter tube 104, and at least a portion of the distal segment 226 extends into and/or through catheter tube 104. As previously stated, in at least some embodiments, a distal end of the distal segment 226 can extend distally past a distal tip of the catheter tube 104 when the access system 200 is in the fully deployed state.
  • the distal segment 226 may be relatively shorter and may function as a substantially atraumatic tip for the medial segment 224, and at least a portion of the medial segment 224 may be introduced into the catheter tube 104.
  • the medial segment 224 can provide a straightened path through at least a proximal portion of the catheter tube 104.
  • the distal segment 226 can include any of the tip features previously discussed and may aid in preventing trauma to the catheter and the blood vessel, and the medial segment 224 can straighten out at least a portion of the catheter tube 104 of the system 100 as the medial segment 224 is advanced through this at least a portion of the catheter tube 104.
  • the medial segment 224 can provide a straight or straightened flow path, relative to a flow path that is defined by the preplaced catheter system 100 prior to use of the system 200.
  • the fluid path 220 through the deployed system 200 can be substantially straight or rectilinear, or can be gently sloped or gradually bent (e.g., without sharp turns or kinking) along the length of at least the medial segment 224 when the system 200 is deployed within the preplaced catheter system 100.
  • the medial segment 224, or at least a distal portion thereof, can be sized to slide or otherwise be advanced through at least a portion of the lumen 108 of the catheter tube 104.
  • the medial segment 224 may not extend into the catheter tube 104.
  • an outer diameter of the medial segment 224 is larger than an inner diameter of the catheter tube 104 and may be prevented from entering the proximal end of the catheter tube 104.
  • the connector 202 includes a reinforcing member 230, which may also or alternatively be referred to herein as a reinforcement member.
  • the reinforcing member 230 comprises a tubular member, such as a needle-like element or reinforcing cannula 232.
  • the reinforcing cannula 232 may also or alternatively be referred to herein as a reinforcing tube.
  • the reinforcing cannula 232 may be formed from a metallic hypotube.
  • the reinforcing member 230 can provide external or lateral support to the distal segment 226 to prevent buckling and/or kinking of the distal segment 226 during forward advancement of the cannula 204.
  • the distal tip 227 of the distal segment 226 can encounter resistive forces as the distal segment 226 is advanced distally into the catheter tube 104.
  • distally directed forces can be provided to a proximal end of the distal segment 226 by the relatively stiffer or reinforced (e.g., axially or longitudinally strengthened) medial segment 224, and the forces that are resistive to distal advancement of the distal segment 226 can tend to act in generally the opposite direction (e.g., generally proximally) at the distal end of the distal segment 226.
  • These generally oppositely directed forces can tend to compress the distal segment 226, causing the distal segment 226 to buckle, bow, bend, kink, or displace laterally.
  • the reinforcing member 230 can counter these lateral forces, thereby preventing buckling or kinking and facilitating insertion of the distal segment 226 into and through the catheter tube 104.
  • the inner diameter of the reinforcing cannula 232 can be such that the outer diameter of each of the distal segment 226 and at least a distal portion of the medial segment 224 can fit therein.
  • the fit may desirably be relatively close, such that there is minimal clearance between the inner surface of the reinforcing member 230 and the outer surface of each of the distal and medial segments 226, 224.
  • an inner diameter (e.g., a maximum transverse dimension of an inner perimeter, circumference, and/or profile) of the reinforcement member 230 may be larger than an outer diameter (e.g., a maximum transverse dimension of an outer perimeter, circumference, and/or profile) of at least one of the distal and medial segments 226, 224 by no more than 5, 10, 15, 20, 25, or 30 percent.
  • the cannula 204 can be said to slide through the reinforcing cannula 232 during advancement and withdrawal (e.g., transitions between the retracted and advanced states).
  • the reinforcing cannula 232 fully covers or encompasses the distal segment 226 in the fully retracted state, which may also be referred to as the set, ready, initial, pre-deployed, or proximal state, position, orientation, or configuration.
  • the deployed state may also or alternatively be referred to as an advanced, aaccttiivvee,, or distal state, position, orientation, or configuration.
  • a proximal tip of the distal segment 226 and a distal tip of the medial segment 224 may be positioned within the reinforcing cannula 232 when in the retracted state, as shown.
  • the medial segment 224 can terminate at a distal terminus 250, which may correspond with the distalmost tip of the medial segment 224.
  • the medial segment 224 includes a tubular member having a substantially flat or planar transversely oriented face at the distal terminus 250. This transverse face abuts a substantially flat or planer transversely oriented face at a proximal tip of a tubular member of the distal segment 226.
  • a heat shrink tube can extend over these abutting surfaces, which can join or assist in joining the medial and distal tubular members to each other.
  • the distal terminus 250 and/or the interface 252 can be positioned within the reinforcement member 230. This can ensure that the full length of the distal segment 226 is reinforced when the distal tip 227 begins to encounter resistance to distal advancement of the cannula 204. For example, as shown In FIG. 7,
  • the distal tip 227 of the distal segment 226 of the cannula 204 is substantially flush with or slightly recessed relative to a distal tip of the reinforcing tube 232 when the cannula 204 is in the retracted position, and a proximal tip of the distal segment 226 is at the interface 252, which is likewise positioned within the reinforcing tube 232.
  • the distal tip 227 of the cannula 204 advances distally past the distal tip of the reinforcing tube 232 and may, in some instances, be susceptible to encountering resistive forces, such as by coming into contact with a portion of the pre-placed catheter tube 104 that is kinked, bent, curved, or otherwise poses resistance to passage therethrough.
  • a length of the reinforcement member 230, and/or a length of the distal segment 226 that is positioned within the reinforcement member 230 when in the set position can be greater than a distance between a distal tip of the reinforcement member 230 at a position at which the distai segment 226 initially encounters forces resistive to distal advancement as the distal segment 226 is deployed from the set position.
  • the distal tip 227 of the distal segment 226 may be proximally recessed within the reinforcement member 230 by a more significant distance (e.g., by a length that is approximately equal to, or that is on the order of two, three, four or more times greater than, an outer diameter of the distal segment 226) when the cannula 204 is in the fully retracted position.
  • the interface 252 may be positioned proximal to a proximal end of the reinforcement member 230 when the cannula 204 is in the fully retracted position, whereas in other embodiments, the interface 252 may be positioned within the reinforcement member 230 when the cannula 204 is in the fully retracted position.
  • the interface 252 may desirably be positioned within the reinforcement member 230 when the distal tip 227 is first positioned distal of and external to the reinforcement member 230.
  • the interface 252 may be positioned proximal to a proximal tip of the reinforcement member 230 by a distance that is less than or equal to a distance by which the distal tip 227 is recessed relative to a distal tip of the reinforcement member 230.
  • the interface 252 may enter into the proximal end of the reinforcement member 230 at the same time as or earlier than the distal tip 227 exits distally out of the distal end of the reinforcement member 230.
  • the medial segment 224 is sufficiently rigid to independently avoid buckling and/or kinking as the distal segment 226 is advanced through the reinforcing cannula 232 and into and through the preplaced catheter tube 104.
  • an unsupported length of the medial segment 224, relative to the reinforcing cannula 232 can be self-supporting, intrinsically supported, or otherwise sufficiently rigid avoid buckling and/or kinking that might otherwise occur if the medial segment 224 were instead formed solely of the same material and geometric configuration as the distal segment 226 — e.g., if the medial and distal segments 224, 226 were formed of a continuous tube of a single material of uniform construction (e.g., uniform hardness, thickness, and diameter) and the medial segment 224 were not reinforced, or stated otherwise, if the medial segment 224 consisted solely of a continuous extension of the soft and/or flexible distal segment 226.
  • the medial segment 224 may be “unsupported,” such as by not having a reinforcing or support structure that is external thereto, the medial segment 224 may nevertheless be self-supported.
  • a portion of the medial segment 224 positioned proximal to the reinforcing member 230 may not be reinforced or supported by the reinforcing member 230, but may nevertheless be intrinsically supported, e.g., due to its intrinsic rigidity.
  • distally directed forces are applied to the proximal segment 222 of the cannula 204, or stated more generally, are applied to the proximal end of the cannula 204. These distally directed forces tend to urge the medial segment 224 and the distal segment 226 distally. When the distal segment 226 encounters resistive forces to its distal advancement, these resistive or opposing forces are transferred proximally through the cannula 204. Accordingly, during such advancement and resistance events, the media! segment 224 encounters opposing forces at its proximal and distal ends.
  • the medial segment 224 can be configured to withstand deflection from the opposing or compressive forces.
  • the medial segment 224 is formed of a rigid material, such as stainless steel, that has sufficient intrinsic strength to resist the compressive forces without bending (or by bending by insignificant amounts) and/or without buckling or kinking.
  • the medial segment 224 may be self-reinforced, internally reinforced, or intrinsically reinforced, such that a full length of the medial segment 224, whether positioned within or without the reinforcement member 230, may be said to be reinforced.
  • the medial segment 224 may include a separate reinforcement or support component, such as a support tube, as discussed further below (see, e.g., FIGS. 56A, 56B, and 59 and accompanying text).
  • the distal and medial segments 226, 224 may include a continuous polymeric tube of uniform properties and dimensions that spans a full length of each of the distal and medial segments 226, 224.
  • the medial segment 224 can additionally include a reinforcement or support tube that encompasses the polymeric tube.
  • the support tube may have an inner surface that is only slightly larger than, is marginally larger than, and/or that closely conforms to an outer surface of the polymeric tube.
  • an inner diameter (e.g., a maximum transverse dimension of an inner perimeter, circumference, and/or profile) of the support tube may be larger than an outer diameter (e.g., aa maximum transverse dimension of an outer perimeter, circumference, and/or profile) of the inner polymeric tube by no more than 5, 10, 15, 20, 25, or 30 percent.
  • the support tube may be fixedly secured to and/or relative to the polymeric tube.
  • the support tube can have a distal end positioned within the reinforcement member 230 when the cannula 204 is in the retracted state.
  • the support tube can slide within the reinforcement member 230 as the cannula 204 is advanced distally.
  • the support tube can generally maintain a rectilinear profile of the portion of the polymeric tube that is positioned therein. Stated otherwise, the relatively stiffer support tube can resist deflection, bending, buckling, or kinking of the inner polymeric tube.
  • the medial segment 224 can be said to withstand deflection from the opposing or compressive forces.
  • the support tube can be formed of a rigid material, such as stainless steel, that has sufficient strength to counter deflection of the inner polymeric tube as it encounters compressive forces that would tend to cause the polymeric tube to deflect, bend, buckle, or kink.
  • the support tube can thereby prevent bending (or permit bending by insignificant amounts) buckling or kinking of the inner polymeric tube.
  • the medial segment 224 may be self-reinforced or intrinsically reinforced, such that a full length of the medial segment 224, whether positioned within or without the reinforcement member 230, may be said to be reinforced.
  • At least a portion of the distal segment 226 can be reinforced when the cannula 204 is in the retracted state or set position, which reinforcement can be provided by the reinforcement member 230 of the connector 202.
  • at least a portion of the medial segment 224 can be reinforced when the cannula 204 is in the retracted state or set position, which reinforcement can be provided intrinsically, such as by a tube of relatively stiff or rigid material that unitarily constitutes the medial segment 224 or such as by a tube of relatively stiff or rigid material that supports a length of a polymeric tube that is positioned within the relatively stiff tube in the region of the medial segment 224.
  • At least a distal end of the medial segment 224 may be reinforced externally by the reinforcement member 230 when the cannula 204 is in the retraced state.
  • a length of the cannula 204 that is positioned within the connector 202, such as within the connection region 203 and the sheath 205, can be reinforced.
  • a reinforced length of the cannula 204, when in the retracted state can be no less than 50, 60, 70, 80, or 90 percent of a total length of the connector 202.
  • a reinforced length of the cannula 204 when in the retracted state, can be no less than 50, 60, 70, 80, or 90 percent of a total length of the sheath 205. In still other or further embodiments, a reinforced length of the cannula 204, when in the retracted state, can be no less than 50, 60, 70, 80, or 90 percent of a length of the internal cavity 212 of the sheath 205.
  • a reinforced length of the cannula 204 when In the retracted state, can be no less than 50, 60, 70, 80, or 90 percent of a distance between a proximal end of the reinforcement member 230 and a proximal end of the internal cavity 212 of the sheath 205.
  • a substantial length of the cannula 204 can be reinforced throughout movement of the cannula 204 from the retracted position to the fully deployed position.
  • the reinforced length may vary throughout at least a portion of the deployment event, such as when increasing amounts of the distal segment 226 exit from the distal end of the reinforcement member 230.
  • a reinforced length of the cannula 204 varies throughout at least a portion of a deployment event in which the cannula 204 is moved from the retracted state to the fully deployed state, and a minimum reinforced length of the cannula 204 throughout a full deployment event can be no less than 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75 percent of a total length of the cannula 204.
  • the total length of the cannula 204 can be defined, for example, as a distance between the distal tip 227 of the cannula 204 and the proximal tip of the connector 229 (see FIG. 6).
  • the minimum reinforced length may be achieved when the cannula 204 is in the fully deployed state.
  • the reinforcing cannula 232 may be formed of any suitable material.
  • the reinforcing cannula 232 can include or be formed of stainless steel and/or rigid plastic.
  • the reinforcing cannula 232 can be formed of a metallic hypotube.
  • the reinforcing cannula 232 may be attached to the connector 202 in any suitable manner, such as, for example, via press-fit, bonding, or overmolding.
  • the connector 230 comprises a polymeric material that is overmolded onto the reinforcing cannula 232.
  • the reinforcing cannula 232 is omitted,
  • the reinforcing member 230 may instead be formed as a channel or lumen that extends through, e.g., a distal end of the connector 202.
  • the distal end of the connector 202 may be molded or otherwise formed with additional material (e.g., polymeric material), as compared with what is shown in FIG. 7, through which the channel or lumen that forms the reinforcing member 230 extends.
  • At least a portion of the distal end of the connector 202, which includes the connection interface 210, may be extended longitudinally in the proximal direction to define an elongated reinforcing member 230.
  • This alternative reinforcing member may, for example, have the same length as that of the reinforcing tube 232 depicted in FIG. 7, but may instead be formed from additional polymeric material with a lumen extending therethrough.
  • the system 200 can include a friction or resistance element 240, which can resist, regulate, temper, adjust, or otherwise passively respond to relative movement of the connector 202 and the cannula 204.
  • the resistance element 240 comprises an O-ring 242 that is received within an annular channel 244 defined by the proximal segment 222.
  • the O-ring 242 can slide along an inner surface of the connector 202.
  • Any other suitable resistance mechanism is contemplated, such as a saw tooth, ratchet, or other interface between the proximal segment 222 and the connector 202.
  • the resistance element 240 can include friction grease in addition to or instead of other resistance elements that regulate relative movement of the connector 202 and the cannula 204.
  • the connector 202 can be configured to couple with an open catheter system and/or a closed catheter system.
  • the connector 202 may be attached directly to a catheter hub of an open catheter system, while in other embodiments, the open catheter system can include an extension set attached to the catheter hub, and the connector 202 can be attached to a port of the extension set.
  • the reinforcement member 230 includes a protrusion or projection 213 that extends distally from a surface 217 (e.g., a distally facing surface) of the connector 202.
  • the surface 217 may also be referred to as a bottom surface or as a recessed, inner, or internal surface of the connection region 203 of the connector 202.
  • the inner and internal surface descriptors arise from the recessed relationship of the surface 217 relative to adjacent portions of the connector 202, such as relative to a threaded skirt 215 and a central male luer, although the surface 217 is an overall exterior of the connector 202.
  • the projection 213 includes the central male luer, which is formed of polymeric material, and within which a distal portion of the reinforcing tube 232 is positioned. Stated otherwise, the projection 213 includes a distal end of the reinforcing tube 232 encompassed by other material (e.g., polymeric material) that projects distally from the recessed surface 217. In some embodiments, the projection 213 can be coupled directly with an open hub (e.g., the catheter hub 106 in FIG. 1), such as to engage the hub in a fluid-tight seal (e.g., via luer interfaces).
  • an open hub e.g., the catheter hub 106 in FIG. 1
  • the projection 213 can be configured to open or otherwise defeat a valve, septum, or the like of a hub or of an extension set coupled to the catheter hub 106, which can permit fluid communication between the catheter tube 104 and the cannula 204.
  • the projection 213 extends distally from a bottom surface 217 of the connection interface 211 .
  • the connection interface 211 further includes the threaded skirt 215, which may comply with ISO standards for luer fittings.
  • the skirt 215 may include a distal edge 219, which can correspond with a distalmost end or tip of the connector 202.
  • the projection 213 extends distally beyond the distal edge 219 of the connector 202.
  • the coupling interface 210 of the connector 202 can be of any suitable variety.
  • the coupling interface 210 can include threading 225, such as for luer lock interfacing. Similar threading 525, 625 is depicted in FIGS. 10 and 11.
  • the coupling interface 210 can utilize friction fit or other mechanical engagement (e.g., snap fit).
  • friction-fit interfaces are identified as the features 328 and 428 in FIGS. 8 and 9, respectively.
  • An iliustrative snap-fit coupling interface is depicted, e.g., in FIG. 32A, as further discussed below.
  • the reinforcement member 230 and/or the reinforcing cannula 232 may be flush with the inner, recessed, bottom, or distal- facing surface 217 of the connector 202.
  • a distal end of a reinforcing cannula 332 is encompassed by or encased in a material that forms a connector 302.
  • the reinforcement member 230 and/or the reinforcing cannula 232 may project distally from a distally- facing surface of the connector 202, such as from the inner, recessed, bottom, or distal-facing surface 217 of the coupling interface 210. In this manner, the reinforcing reinforcement member 230 and/or the reinforcement cannula 232 can pierce or otherwise defeat valves, stops, etc. of a preplaced catheter system as the connector 202 is coupled to the preplaced catheter system.
  • a catheter hub of a preplaced catheter system may include a septum or a valve that can be pierced, compressed, or otherwise opened by the reinforcement member 230.
  • the projection 213 of the embodiment depicted in FIG. 7, which includes a distal end of the reinforcement cannula 232 therein, may be configured to open or defeat a valved member of the preplaced catheter system — for example, may defeat a valve associated with the catheter hub 106 (see FIG. 1 ) in some instances, and/or may defeat a valve associated with an extension set (see, e.g., FIG. 24) coupled with the catheter hub 106.
  • the distal end of reinforcement members 430, 630, which define projections 413, 613, may be formed solely by distal ends of reinforcement cannulas 432, 632 that project distally from bottom, inner, recessed, or distally facing surfaces 417, 617, respectively.
  • Each reinforcement cannula 432, 632 can be inserted through a valve as its respective connector 402, 602 is coupled with a preplaced catheter system (whether directly to a catheter hub or to a hub of an extension set), in some instances.
  • the reinforcement cannulas 432, 632 can be dimensioned such that the distal tip of the reinforcement cannula 432, 632 is instead positioned at, adjacent to, or slightly proximally recessed from a proximal surface of a valve member as the associated connector 402, 602 is attached to a preplaced catheter system.
  • the respective cannula 404, 604 can be advanced distally to pierce through the valve member while being reinforced by the distal projection of the reinforcement cannula 432, 632.
  • the rigid tube abuts a polymeric tube that forms the distal segment 226, as previously discussed.
  • the polymeric tube of the distal segment 226 and the stainless steel tube of the medial segment 224 can abut at an interface and be connected to each other via heat shrink tubing.
  • a polymeric tube may extend continuously along both the distal and medial segments 226, 224.
  • the rigid tube of the medial segment 224 may encompass that portion of the polymeric tube that extends proximally from the distal segment 226.
  • a single polymeric tube e.g., of polyimide
  • a second tube such as the support tube previously described, can sheath a portion of the polymeric tube and extend from the interface 252 all the way proximally to the proximal connector 229.
  • the cannula 204 can include (1 ) a distal segment 226, formed solely of a polymeric tube extending distally from the interface 252 to the distal tip 217 of the cannula 204, and (2) a medial segment 224, formed of a continuous proximal extension of the polymeric tube and a second rigid support tube that sheaths or encompasses the proximal extension of the polymeric tube, with each of said continuous proximal extension of the polymeric tube and the support tube extending proximally from the interface 252 and terminating at the proximal connector 229.
  • the rigid tube of the medial segment 224 may be extended proximally through an interior of the proximal segment 222.
  • the proximal segment 222 may include a diametrically larger piece (e.g., of plastic) that encases a proximal portion of the medial segment 224.
  • the rigid cannula (e.g., which may be metallic) of the medial segment 224 may extend proximally to the connector 229.
  • the proximal segment 222 has been described herein as a portion of the cannula 204.
  • the elongated molded piece that forms the illustrated proximal segment 222 may alternatively be described as an elongated proximal connector 229 (e.g., an elongated luer connector) that extends distally. That is, the proximal segment 222 may be viewed as a distal extension of the connector 229.
  • FIG. 8 depicts a distal portion of another embodiment of an access system 300, which can resemble other access systems disclosed herein, such as, for example, the access system 200. Accordingly, features of the access system 300 are designated with reference numerals similar to those of the access system 200, with the leading digit “2” being replaced with “3.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the access system 300 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the access system 300.
  • access system 300 can suitably be used within the base catheter system 100 and other preplaced catheters and catheter systems described herein. That is, disclosures regarding various access systems 300 can be appropriately applied to other access systems described herein, in the interest of streamlining the present discussion. This pattern of disclosure applies equally to further embodiments depicted in the various figures and described herein, wherein the leading digits may be further altered.
  • the access system 300 includes a connection interface 310 that has a friction-fit arrangement, rather than threading.
  • a distal tip of a reinforcement tube 332 is flush with an inner surface 317 of the connection interface 310.
  • a cannula 304 is shown in a retracted orientation. In this orientation, a distal tip 327 of the cannula 304 is recessed slightly from a distal tip of the reinforcement tube 332.
  • FIG. 9 depicts another embodiment of an access system 400 that includes a connector 402 having a connection interface 410 that likewise has a friction-fit arrangement.
  • the projection 413 is defined by a distal end of a reinforcement tube 432 that extends distally from an inner or recessed surface 417 of the connection interface 410.
  • a distal tip of the reinforcement tube 432 is proximally recessed relative to a distal edge 419 of the connector 402.
  • a distal tip 427 of the cannula when a movable cannula 404 is in a retracted position, a distal tip 427 of the cannula is substantially flush with a distal tip of the reinforcement tube 432. In this retracted orientation, the distal tip 427 of the cannula 404 is distally spaced from the inner or recessed surface 417 and is proximally spaced from the distal edge 419 of the connector 402.
  • FIGS. 10 and 11 depict additional embodiments of access systems 500, 600 that resemble the access systems 300, 400, respectively.
  • the access systems 500, 600 have connectors 502, 602 having connection interfaces 510, 610 that include threading 525, 625.
  • the access systems 500, 600 include reinforcement members 530, 630 that include reinforcement tubes 532, 632.
  • the access systems 300, 400, 500, 600 can be particularly well suited for coupling with closed intravenous catheter systems.
  • the reinforcement tubes 332, 432, 532, 632 may be spaced from an outer septum or cover of the closed IV catheter system.
  • the reinforcement tubes 332, 432, 532, 632 can be dimensioned to extend through the outer septum or cover of the closed IV catheter, but a distal tip thereof may (1 ) be at or proximally spaced from a proximal surface of a valve (or plug or inner septum), (2) not extend through the valve, and/or (3) not contact the valve, as discussed further below.
  • FIG. 12 is a perspective view of an embodiment of a closed catheter system 700, which may also be referred to herein as a closed base catheter system 700.
  • a closed catheter system is contemplated, such as, for example, a closed intravenous catheter system.
  • the closed base catheter system 700 can comprise any of the NEXIVATM lines of catheters (e.g., the DIFFUSICSTM line) available from Becton Dickinson. Certain of such closed catheter systems may have an extension set 802 integrated therein.
  • a hub 806 of the extension set 802 includes a side port 813 with an extension tube 817, a connector 818, and a removable vent fitting 819, similar to extension set arrangements that may be used with open intravenous catheter assemblies (e.g., such as the extension set depicted in and described with respect to
  • the hub 806 may also be referred to as a catheter hub.
  • the closed catheter system 700 can include a removable needle assembly
  • the needle assembly 721 that includes a needle 720 connected to a needle hub 722.
  • the needle assembly 721 can be coupled with the catheter hub 806 and used during insertion of a catheter tube 704 into the vasculature of a patient, and can be removed from the catheter hub 806 thereafter.
  • the needle 720 and its two-part hub 722 can be inserted into the catheter hub 806 and the catheter tube 704 during assembly of the closed catheter system 700, and can be packaged in such a preassembled configuration, such as that depicted in FIG. 12.
  • the catheter system 700 is shown in an insertion configuration.
  • the needle 720 extends from a distal tip of the catheter 704 to permit insertion of the catheter tube 704 into the vasculature of a patient.
  • the needle 720 can be fixedly attached to the needle hub 722.
  • the needle hub 722 is a two-part hub that provides shielding capabilities to a distal tip of the needle 720 to avoid needle sticks when the needle 720 is withdrawn from the catheter hub 806 after the catheter tube 704 has been introduced into the vessel of the patient.
  • FIG. 14 is a cross-sectional view of the catheter hub 806 and the catheter tube 704 of the closed catheter system 700 in an operational state in which the needle 720 has been fully removed from the catheter tube 704 and from the catheter hub 806.
  • the catheter hub 806 can include a distal port 807 in fluid communication with the catheter tube 704, a proximal port 809 that is described below, and the side port 813 of the integrated extension set 802, to which the extension tube 817 and connector 818 (FIG. 12) are coupled.
  • Each of the distal and side ports 807, 813 is in continuous fluid communication with an inner chamber 810.
  • access systems e.g., the access systems 300, 400, 500, 600
  • the access systems may not include their own extension sets (e.g., such as the extension set depicted in FIG. 24), as the catheter hub 806 of the closed base catheter system 700 already includes an extension set integrated therein.
  • the distal connection interfaces of the access systems 300, 400, 500, 600 depicted in, e.g., FIGS. 8-11 may be particularly well-suited for interfacing with the closed catheter system 700. For example, friction-fit or snap-fit connectors may connect well with certain embodiments of the proximal port 809.
  • the proximal port 809 can include a plurality of components coupled thereto or therein.
  • the proximal port 809 can include an outer or proximal septum or cover 851 , an inner or distal septum or plug 852, and a retainer 853.
  • the septa 851 , 852 may be formed of any suitable elastomeric materials.
  • the retainer 853 may be formed of a relatively rigid polymeric material and may interface with a polymeric housing of which the catheter hub 806 is formed to retain the septa 851 , 852 within the proximal port 809.
  • the needle 720 extends through the retainer 853 and the septa 851 , 852 of the proximal port 809, through the catheter hub 806, and through the catheter tube 704 when the closed catheter system 700 is in the insertion configuration.
  • the needle 720 may more generally be referred to as a piercing member or as a piercing implement.
  • the needle 720 may be replaced with any other suitable piercing member or piercing element, such as, for example, a trocar.
  • the proximal port 809 may also be referred to as an implement port.
  • certain embodiments of access systems are able to interface with the proximal port 809 in an atypical fashion by coupling with the proximal port 809 and passing a cannula (e.g., 304, 404, 504, 604) through the plug 852 and into the catheter tube 704.
  • a cannula e.g., 304, 404, 504, 604
  • the cannula can, upon passing through the plug 852, achieve fluid communication with the inner chamber 810 and/or the catheter tube 704.
  • the cannula e.g., 304, 404, 504, 604
  • fluid is able to pass through the cannula, and hence is able to pass through the plug 852 and, more generally, through the proximal port 809.
  • multiple access events through the plug 852 in this manner are possible.
  • the plug 852 can again self-seal upon removal of the cannula (e.g., 304, 404, 504, 604).
  • the distal septum or plug 852 may additionally or alternatively be referred to herein as a valve or valve member 852. Further, the distal septum, plug, valve, or valve member 852 may also or alternatively be referred to as a seal or sealing member. [00162] In view of the foregoing, the septa 851 , 852 and the retainer 853 may be described in additional or alternative terms.
  • the proximal port 809 includes a valve assembly 850 that can permit selective fluid communication between the inner chamber 810 and the proximal port 809.
  • the valve assembly 850 is configured to fluidically seal against the needle 720 when the needle 120 is fully inserted therethrough, such as in the insertion configuration depicted in FIG. 12, and is configured to self-seal so as to prevent fluid from egressing from the inner chamber 810 and through the proximal port 809 upon removal of the needle 720 therefrom to achieve the access configuration depicted in FIG. 13.
  • the valve assembly 850 of the proximal port 809 can include the proximal septum 851 , the distal septum 852, and the retention member or retainer 853.
  • the retainer 853 can comprise a generally tubular element that interfaces with a body of the catheter hub 806 to retain the proximal and distal septa 851 , 852 within the proximal port 809. That is, the retainer 853 may cooperate with a housing portion of the hub 806 to hold the septa 851 , 852 in place within the proximal port 809.
  • the illustrated valve assembly 850 includes multiple septa 851 , 852, only the distal septum 852 may provide the valving functionality of the valve assembly 850 discussed above, and further discussed below.
  • the proximal septum 851 which is also or alternatively referred to as a cover, includes an opening 854, which may be centered relative to the port 809.
  • the opening 854 may be a permanent opening.
  • the needle 720 can extend through the opening 854 of the proximal septum 851 .
  • the opening 854 may be preformed and/or may be sufficiently large such that the opening 854 does not self-seal upon removal of the needle 720 therefrom.
  • the retainer 853 can include an opening 855, which can be larger than the opening 854 of the proximal septum 851 .
  • the opening 855 can be concentric with the opening 854.
  • a reinforcement member of the access system e.g., the reinforcement member 430, 630 of the access system 400, 600, respectively
  • a distal tip of the reinforcement member e.g., the distal tip of the reinforcement tube 432, 632
  • FIGS. 1-10 One such illustrative coupling event and coupling configuration are depicted in FIGS.
  • the distal tip of the reinforcement member may be fixed in this position relative to the valve 852.
  • the reinforcement member e.g., 430, 630
  • a movable/deployable cannula e.g., 404, 604
  • a longitudinal axis of the reinforcement tube e.g., 432, 632
  • a line that extends through the sealable region 856 of the valve 852 which line corresponds to a sealed tract from which the needle 720 has previously been removed (this may also be referred to as a needle tract through the sealable region 856).
  • the reinforcement member (e.g., the reinforcement tube) does not contact the valve 852 or extend into or through the valve 852. Rather, the cannula (e.g., 404, 604) of the access system is extended out of the reinforcement member (e.g., the reinforcement tube 432, 632) and then through the sealable region 856 of the valve 852.
  • a reinforcement member e.g., 330, 530 of the access system (e.g., 300, 500) can remain external to, recessed from, or otherwise not extend through the openings 855, 854 of the retainer 853 and the proximal septum 851 , respectively.
  • a distal tip of the reinforcement member e.g., the distal tip of the reinforcement tube 332, 532 may be proximally recessed from a proximal surface of the distal septum or valve 852.
  • the distal tip of the reinforcement member may sufficiently recessed from the valve 852 so as to also be at or proximally recessed from a proximal surface of the cover or proximal septum 851.
  • the distal tip of the reinforcement member e.g., 330, 530
  • the reinforcement member can align a movable/deployable cannula (e.g., the cannula 304, 504) of the access system with a longitudinal axis of the valve 852.
  • a longitudinal axis of the reinforcement tube (e.g., 332, 532) can be centered on and colinear with the line through the sealable region 856 of the valve 852 that corresponds to a sealed tract from which the needle 720 has previously been removed (e.g., the needle tract through the sealed region 856), as previously described.
  • An imaginary extension of this line in the proximal direction can extend through the openings 855, 854 of the retainer 853 and the proximal septum 851 , respectively, and be aligned with the longitudinal axis of the reinforcement tube.
  • the reinforcement member e.g., 330, 530
  • the reinforcement tube e.g., 332, 532
  • the cannula e.g., 304, 504 of the access system is extended out of the reinforcement member (e.g., 330, 530), then through the proximal septum 851 , and then through the sealable region 856 of the valve 852 along a substantially rectilinear path.
  • the distal end of the deployable cannula (e.g., any of the cannulae 304, 404, 504, 604 of the access systems 300, 400, 500, 600) can successfully be extended through the valve 852 without damaging or kinking the cannula (e.g., 304, 404, 504, 604) and without damaging the valve 852.
  • coupling the access system (e.g., 300, 400, 500, 600) with the proximal port 809 can center the reinforcement member (e.g., 330, 430, 530, 630) relative to the valve 852 and thereby align the cannula (e.g., 304, 404, 504, 604) with the valve 852, such that the cannula (e.g., 304, 404, 504, 604) can be inserted along the same path through the valve 852 or through the same portion of the valve 852 from which the needle 720 has previously been removed (e.g., the needle tract through the sealable region 856), which may facilitate or enable insertion of the cannula (e.g., 304, 404, 504, 604) through the valve 852.
  • the reinforcement member e.g., 330, 430, 530, 630
  • reinforcement features as described elsewhere herein can make such insertion of only the cannula (e.g., 304, 404, 504, 604) through the valve 852 possible.
  • the cannula may bend or kink upon contact with the valve 852, which can prevent insertion of the cannula through the valve 852.
  • maintaining the reinforcement tube (e.g., 432, 632) external to the valve 852 (or proximally recessed from a proximal surface of the valve 852) prior to and during insertion of the cannula (e.g., 404, 604) through the valve 852 can maintain the valve 852 in a relatively relaxed or uncompressed state, which can facilitate distal movement of the cannula (e.g., 404, 604) through the valve 852.
  • damage to the valve 852 such as coring of the valve 852 by a distal tip of the reinforcement tube (e.g., 432, 632) and/or permanent stretching or deformation of the valve 852 by a relatively larger outer diameter of the reinforcement tube (e.g., 432, 632), can be avoided.
  • valve 852 it can be advantageous to advance the cannula through the valve 852 without first inserting a separate supporting or reinforcing member into or through the valve 852 (e.g., a reinforcing member of a larger diameter that could stretch out or deform the valve 852 and/or of a variety which could undesirably core a portion of the valve 852 upon passage therethrough).
  • a separate supporting or reinforcing member e.g., a reinforcing member of a larger diameter that could stretch out or deform the valve 852 and/or of a variety which could undesirably core a portion of the valve 852 upon passage therethrough.
  • valve 852 it can be advantageous to advance the cannula through the valve 852 independently, on Its own, or without doing so through a separate member (e.g., reinforcement or support member) that has previously been advanced into or through the valve and that remains positioned in or through the valve so as to define an open channel (e.g., corresponding to the inner lumen of the support member) through at least a portion of the valve for subsequent passage of the cannula.
  • a separate member e.g., reinforcement or support member
  • an open channel e.g., corresponding to the inner lumen of the support member
  • the valve 852 can remain sealed during subsequent use of the integrated extension set 802.
  • an access system e.g., 300, 400, 500, 600
  • use of the access system with closed catheter system 700 can, upon removal of the access system, permit the inner septum 852 to once again plug or seal the proximal port 809.
  • the integrated extension set 802 of the closed catheter system 700 can be used to access the vasculature of the patient (e.g., for an infusion or aspiration event) via the placed catheter tube 704 in the same manner as may have been accomplished prior to use of the access system (e.g., 300, 400, 500, 600) with the closed catheter system 700.
  • a deployable cannula e.g., 304, 404, 504, 604
  • an access system e.g., 300, 400, 500, 600
  • the valve 852 remains sufficiently strong and fluid-tight to permit use of the closed catheter system 700 for power injections through the side port 813 after removal of the access system (e.g., 300, 400, 500, 600).
  • use of an access system (e.g., 300, 400, 500, 600) with the closed catheter system 700 has no adverse effect on the valve 852, such that after 1 , 2, 3, 4, 5, 10, 15, 20, or 25 or more coupling and decoupling cycles of one or more access assemblies (e.g., 300, 400, 500, 600) with and from a closed catheter system 700, the valve 852 of the closed catheter system 700 continues to operate in its original manner.
  • the valve 852 can continue to maintain a fluid-tight seal during a power injection through the closed catheter system 700 after one or multiple coupling/decoupling event or events.
  • FIG. 15 is a perspective view of another embodiment of an access system 1000 configured to be coupled with embodiments of a base catheter system.
  • the access system 1000 is configured to be coupled with an open base catheter system, whether directly (e.g., by direct attachment to a catheter hub) and/or indirectly (e.g., by direct attachment to a proximal port of an extension set that is attached to a catheter hub), as further discussed below.
  • the access system 1000 is shown in a fully retracted or undeployed state.
  • the access system 1000 includes a connector 1002 and a cannula 1004 that is selectively advanceable and retractable relative to the connector 1002.
  • the cannula 1004 can include a connector 1029 at a proximal end thereof.
  • the connector 1029 is a female luer.
  • the connector 1002 can include a connection interface 1010 and a reinforcement member 1030.
  • the reinforcement member 1030 includes a distal projection 1013 that extends a significant distance past a distal face of the connection interface 1010.
  • the distal projection 1013 may be narrower and more elongated than a luer interface, in some instances.
  • the access system 1000 includes an internal stop, hub, or follower 1060, to which a proximal segment 1022 of the cannula 1004 is attached.
  • the follower 1060 can be sized to prevent the cannula 1004 from being retracted fully from a sheath 1005. Stated otherwise, a proximal end of the sheath 1005 and the follower 1060 can cooperate to delimit proximal movement of the cannula 1004.
  • the follower 1060 can have a greater radial dimension than an opening 1061 at a proximal end of the sheath 1005.
  • the follower 1060 can be fixedly secured to one or more components of the cannula 1004 (e.g., the proximal segment 1022 and/or a medial segment 1024) and can move in response to movement of the cannula 1004. Stated otherwise, the follower 1060 can move in unison with the cannula 1004 and in response to forces imparted to the cannula 1004. In particular, the follower 1060 is not directly accessible by a user, and instead moves solely in response to forces applied to the proximal segment 1022 of the cannula 1004 by a user at an exterior of the sheath 1005.
  • the follower 1060 can restrict, inhibit, or prevent rotational movement of the cannula 1004 relative to the sheath 1005 about a longitudinal axis, which these components may have in common. Stated otherwise, the follower 1060 can cooperate with the sheath 1005 to rotationally lock the cannula 1004 relative to the sheath 1005, thus preventing relative rotation of these components about a central longitudinal axis about which the components are concentrically arranged.
  • the follower 1060 includes a protrusion 1062 that fits within a longitudinal groove 1064 defined by the sheath 1005. In other embodiments, the groove/protrusion interface may be reversed.
  • the follower 1060 defines a groove that receives a longitudinal protrusion that extends inwardly from the sheath 1005.
  • the protrusion 1062 and the groove 1064 may be referred to as a rotational alignment mechanism 1065 or as a rotational lock. Any suitable rotational alignment mechanism is contemplated.
  • Other embodiments may permit free rotation between the cannula 1004 and the sheath 1005.
  • some embodiments may be devoid of a rotational alignment mechanism.
  • an interior surface of the sheath 1005 and an exterior surface of the follower 1060 each may be substantially cylindrical so as to readily permit relative rotation.
  • FIG. 17A is a perspective view of the housing 1005, and FIGS. 17B and 170 are separate cross-sectional views of the housing 1005.
  • the groove 1064 which may also be referred to as an internal track, is visible in each view.
  • the housing 1005 includes one or more gripping features 1068.
  • the gripping features 1068 can include one or more of grooves, coverings, coatings, and/or other surface features to enhance grippability, ergonomics, and/or manipulation of the housing 1005.
  • the gripping features 1068 of the illustrated embodiment includes grooves and a high friction layer of material.
  • the gripping features 1068 further include a pair of diametrically opposite raised wings 1069 at a distal end of the housing 1005.
  • the wings 1069 may, in some instances, assist in manipulation of the housing 1005 to rotate the housing 1005 for coupling with the access system 1000 with a connector of a catheter hub or an extension set hub.
  • FIGS. 18A and 18B depict an embodiment of a coupling member 1070 that may be attached to a distal end of the housing 1005, and may form a distal end of the connector 1002.
  • the coupling member 1070 can include any suitable connection interface 1010, such as those previously discussed.
  • the connection interface 1010 includes internal threading, such as may be used, for example, to couple with a threaded luer interface.
  • the coupling member 1070 can define a reinforcing member 1030.
  • the reinforcing member 1030 can include a distal projection 1013 that extends distally from a bottom, inner, or recessed surface 1017 of the connection interface 1010.
  • the distal projection 1013 is formed of two different components.
  • an outer layer of the distal projection 1013 is formed of a polymeric material, and constitutes an extension of a continuous casting or molding of polymeric material of which much of the reinforcing member 1030 is formed.
  • the distal projection 1030 further includes at least a distal end of an internally situated reinforcing tube 1032, such as reinforcing tubes previously described.
  • the reinforcing tube 1032 is embedded within the coupling member 1070.
  • the polymeric portion of the coupling member 1070 is overmolded onto the reinforcing tube 1032.
  • the reinforcing member 1030 can further include an elongated proximal projection 1031 of the polymeric material.
  • the proximal projection 1031 can extend proximally into an internal cavity of the sheath 1005 when the coupling member 1070 is secured to the sheath 1005, as shown in FIG. 16.
  • a lumen 1033 can extend continuously through the proximal projection 1031 and through the reinforcing tube 1032.
  • an internal diameter of the lumen 1033 is substantially constant along a full length of the reinforcing member 1030, or stated otherwise, along a full length of the lumen 1033 that extends from a proximal tip of the proximal projection 1031 to a distal tip of the reinforcing tube 1032.
  • proximal projection 1031 may be omitted, and the reinforcing tube 1032 can be extended proximally, similar to an arrangement such as that depicted in FIG. 7.
  • FIGS. 19A and 19B are perspective views of the follower 1060, and FIG. 190 is a cross-sectional view of the follower 1060.
  • the longitudinally extending protrusion 1062 is shown in each view.
  • the follower 1060 defines a proximal cavity 1071 sized to receive a distal end of the proximal segment 1022 of the cannula 1004 therein.
  • the distal end of the proximal segment 122 is adhered to the follower 1060 (see FIG. 23A).
  • the follower 1060 can further define a distal cavity 1072 that is enlarged relative to an outer diameter of the medial segment 1024 of the cannula 1004, such that the medial segment 1024 can readily pass through the distal cavity 1072 (see FIG. 23A).
  • the follower 1060 can include an opening 1073 through a sidewall 1074, which sidewall 1074 separates the proximal and distal cavities 1071 , 1072 from each other.
  • the opening 1073 can be sized to permit passage therethrough of the medial segment 1024 of the cannula 1004.
  • a proximal end of a tube that forms at least a portion of the medial segment 1024 can extend through the opening 1073 and be embedded in a distal end of the tube that forms at least a portion of the proximal segment 1022 of the cannula 1004, as shown in FIG. 23A.
  • these tubes may be adhered to one another.
  • the tubes of the cannula 1004 may be attached to one another and then passed distally through the opening 1073, at which point the distal end of the proximal tube can be adhered to the follower 1060 within the cavity 1071 .
  • FIG. 20 is a cross-sectional view of an embodiment of the connector 1029.
  • the connector 1029 includes a female luer interface 1074.
  • the connector 1029 further defines a cavity 1076 sized to receive a proximal end of the proximal segment 1022 of the cannula 1004 therein (see, e.g., FIG. 16).
  • FIG. 21 is a partially exploded elevation view of the cannula 1004 showing a tie layer 1080 separated from a distal tube 1081 and a medial tube 1082.
  • the distal tube 1081 is included in the distal segment 1026 of the cannula 1004 and the medial tube 1082 is included in the medial segment 1024 of the cannula 1004.
  • the distal tube 1081 can be of any suitable material for the distal segment 1026, such as those previously described.
  • the distal tube 1081 is formed of polyimide.
  • the medial tube 1082 likewise may be formed of any suitable material for the medial segment 1024.
  • the medial tube 1082 comprises a stainless steel tube.
  • the tie layer 1080 can be used to join the tubes 1081 , 1082 together.
  • the tie layer 1080 can comprise a thin-walled tube of heat shrink material that is advanced over at least a proximal end of the distal tube 1081 and a distal end of the medial tube 1082. The heat shrink tube can then be heated to securely attach to the ends of the tubes 1081 , 1082 together.
  • the distal tube 1081 comprises a polymeric material and the medial tube 1082 comprises a metallic material.
  • the tie layer 1080 can comprise any suitable material.
  • the tie layer 1080 includes a tube of heat-shrinkable polyethylene terephthalate (PET).
  • FIG. 22 is an enlarged cross-sectional view of the cannula 1004 with the tie layer 1080 in place over the tubes 1081 , 1082.
  • the adjoined ends of the tubes 1081 , 1082 abut one another.
  • each tube 1081 , 1082 end has a substantially flat or planar surface that is transverse to a longitudinal axis of the cannula 1004. These transverse surfaces abut one another to provide a surface of continuous contact. In some instances, abutment along a plane that is perpendicular to a longitudinal axis through the tubes 1081 , 1082 can inhibit bending at that junction of the tubes 1081 , 1082.
  • the tubes 1081 , 1082 may be less inclined to bend or kink at the junction, as compared, for example, to circumstances in which space may be provided between the adjacent tube ends. Consistent with other disclosures herein, the tubes 1081 , 1082 may be said to abut one another at an interface 1052 of the cannula 1004.
  • the distal end of the medial tube 1082 represents a distal terminus 1050 of the medial member 1024.
  • the inner diameters of the tubes 1081 , 1082 are substantially identical, such that a lumen 1021 of the cannula 1004 is substantially smooth along at a transition from the distal tube 1081 to the medial tube 1082. In some instances, a smooth transition can inhibit or prevent hemolysis of blood due to its passage through the interface 1052.
  • a distal tip of the tie layer 1080 can be proximally spaced from the distal tip of the cannula 1004. Such an arrangement may permit the distal tip of the tie layer to contact an internal surface of the catheter tube 104 at a distal tip of the catheter tube 104 to delimit proximal movement of the cannula 1004 relative to the catheter tube 104. This may be an effective manner for limiting an amount of the cannula 1004 that can extend past the distal end of the catheter tube 104.
  • contact between the distal end of the tie layer 1080 and a narrowed inner surface of the catheter tube 104 at the distal tip of the catheter tube 104 can provide tactile feedback to a user regarding a position of the cannula 1004 relative to the catheter tube 104, and in particular, to alert the user that the cannula
  • FIG. 23A is a cross-sectional view of a generally proximal portion of the access system 1000 when the access system 1000 is in a retracted state, or stated otherws, when the cannula 1004 of the access system 1000 is in a retracted state.
  • the follower 1060 may be substantially at a proximal end of the sheath
  • FIG. 23B is a cross-sectional view of a distal portion of the access system 1000 in the retracted state.
  • the interface 1052 of the cannula 1004 can be positioned within the reinforcement member 1030.
  • an entirety of a proximal end of the distal segment 1026 of the cannula 1004, including a proximal tip of the distal segment 1026, and the distal terminus 1050 of the medial segment 1024 each can be positioned within the reinforcement member 1030 when the cannula 1004 is in the retracted state.
  • the interface 1052 is positioned within the proximal extension 1031 of the reinforcement member 1030 in this operational state.
  • the distal tube 1081 has a distal tip that is slightly recessed relative to a distal tip of the reinforcement tube 1032 of the reinforcement member 1030. In the illustrated embodiment, an entirety of the distal tube 1081 is positioned within the reinforcement member 1030. A distal end of the distal tube 1081 is within the reinforcement tube 1032 of the reinforcement member
  • the reinforcement member 1030 can prevent the distal tube 1081 from bending or kinking during an insertion event, due to the reinforcement provided by the relatively close fit between the inner diameter of the reinforcement member 1030 and the outer diameter of the distal tube 1081.
  • FIG. 24 is an exploded perspective view of an embodiment of a base catheter assembly 1100 that includes an embodiment of an open intravenous catheter assembly 1101 and an embodiment of an extension set 1150 that is couplable to the open intravenous catheter assembly 1101.
  • the catheter assembly 1101 includes a catheter hub 1106 and a catheter tube 1104, which can resemble the catheter hub 106 and the catheter tube 104 described previously.
  • the extension set 1150 includes an extension hub 1180 that includes a distal port 1181 , a side port 1182, and a proximal port 1183.
  • the distal port 1181 can include a connector 1151 of any suitable variety configured to couple with the catheter hub 1106.
  • the connector 1151 comprises a rotatable luer lock connector for selective engagement of a male luer 1171 with the catheter hub 1106.
  • the side port 1182 includes an extension tube 1157 coupled thereto.
  • a connector 1158 is attached to an opposite end of the extension tube 1157.
  • the proximal port 1183 can include a connector 1162, to which a connection interface of any suitable access system (e.g., 200, 300, 400, 500, 600, 1000) can be attached.
  • Each of the distal port 1181 , the side port 1182, and the proximal port 1183 can be in fluid communication with an inner chamber 1173 (see FIG. 25) defined by the extension hub 1180.
  • the proximal port 1183 may permit selective fluid communication with the inner chamber 1173 via the valve 1184.
  • FIG. 25 is a cross-sectional view of the base catheter assembly 1100 in an assembled state.
  • the cross-sectional view is taken such that the side port 1182 is not shown.
  • the male luer 1171 can be inserted into and fluidically sealed with the female luer of the catheter hub 1106.
  • the male luer 1171 can have an elongated lumen 1172 at an interior thereof, which corresponds with a distal end of the inner chamber 1173.
  • the lumen 1172 can be a necked down or narrowed section of the inner chamber 1173.
  • the catheter hub 1106 provides a first unsupported length between a distal tip of the access system 1000 and a proximal end of the catheter tube 1104 when the access system 1000 is coupled directly to the catheter hub 1106, whereas the catheter hub 1106 and the extension hub 1180, when coupled together, provide a second unsupported length between the distal tip of the access system 1000 and the proximal end of the catheter tube 1104, when the access system 1000 is directly coupled, to the extension hub 1180, and the second unsupported length is significantly greater than the first unsupported length.
  • FIG. 26 is a side elevation view of the access system 1000 in the retracted state coupled with the assembled base catheter assembly 1100, which includes the extension set 1150 that has the side port 1182.
  • FIG. 27 is a cross-sectional view of a distal portion of the access system 1000 in the retracted state while coupled with the assembled base catheter assembly 1100. As with FIG. 25, the cross-sectional view is taken such that the side port 1182 of the extension set 1150 is not shown.
  • the distal projection 1013 of the reinforcement member 1030 extends into the inner chamber 1173 of the extension hub 1180.
  • the distal tip of the distal projection 1013 is positioned within a proximal end of the narrowed lumen 1172 of the male luer 1171.
  • the distal tip of the projection 1013 is proximally spaced from a proximal tip 1107 or proximal edge of the catheter hub 1106. Accordingly, as previously discussed, the cannula 1004 has a greater distance to travel through the extension hub 1180 and the catheter hub 1106 in order to enter the proximal end of the catheter tube 1104 than Is needed when an access system 1000 is coupled directly to a catheter hub 1106.
  • the distal projection 1013 may be longer and/or narrower for access assemblies that are Intended for use with extension sets than are those intended for use directly with catheter hubs 1106. Moreover, in the illustrated embodiment, a distal end of the distal projection 1013 is advanced into the narrowed lumen 1172 of the male luer 1171. Correspondingly, in some embodiments, the distal projection 1013 may be longer than and/or narrower than a standard male luer.
  • FIG. 28 is a cross-sectional view of the access system 1000 in a fully deployed state while coupled with the assembled base catheter assembly 1100.
  • FIGS. 29A-29C are close-up cross-sectional views of various portions of the access system 1000 and the base catheter assembly 1100 in this operational configuration.
  • FIG. 29A depicts a generally intermediate portion of the access system 1000
  • FIG. 29B depicts a generally distal portion of the access system 1000 and a proximal portion of the base catheter assembly 1100
  • FIG. 290 depicts the distal ends of the access system 1000 and the base catheter assembly 1100.
  • the proximal extension 1031 of the reinforcement member 1030 can delimit distal movement of the cannula 1004.
  • the proximal segment 1022 of the cannula 1004 may be fixedly secured to the follower 1060.
  • the distal cavity 1072 of the follower 1060 can have a sufficiently large inner diameter to receive a proximal end of the proximal extension 1031 of the reinforcement member 1030 therein.
  • the distal cavity 1072 of the follower 1060 advances over the proximal end of the proximal extension 1031 until contact is made between the sidewall 1074 of the follower 1060 and the proximal extension 1031. This contact can prevent further distal advancement of the cannula 1004.
  • the distal segment 1026 when the cannula 1004 is in the fully deployed position, the distal segment 1026 extends into and through the catheter tube 1104.
  • the distal segment 1026 of the cannula 1004 extends a significant distance beyond a distal tip 1109 of the catheter tube 1104.
  • the distal segment 1026 may extend distally beyond the distal tip of the catheter tube 1104 by a distance that is no less than 3, 5, 10, or 15 times greater than an outer diameter of the distal segment 1026.
  • the interface 1052 at which the distal and medial segments 1026, 1024 meet may be positioned proximally relative to the proximal tip 1107 of the catheter tube 1104. Stated otherwise, the distal terminus 1050 of the medial segment 1024 may remain external to the catheter tube 1104, while being positioned distal of the reinforcing member 1030.
  • the intrinsic support or self-reinforcing properties of the medial segment 1024 can inhibit kinking or buckling of the cannula within the elongated, generally unsupported region of the inner chamber 1173 of the extension hub 1180 and the internal chamber of the catheter hub 1106 as the cannula 1004 is advanced distally.
  • the medial segment 1024 may enter, and further, may pass through at least a proximal portion of the catheter tube 1104.
  • the distal and medial segments 1026, 1024 may have substantially the same outer diameter dimensions, such that the medial segment 1024 could readily follow the distal segment 1026 into the catheter tube 1104.
  • Relative lengths of, e.g., the reinforcement member 1030 (e.g., the proximal projection 1031 thereof) and the cannula 1004 can be adjusted to ensure that a distal tip of the cannula 1004 reaches a desired position relative to the distal tip of the catheter tube 1104 when the cannula 1004 is in the fully deployed state.
  • a distal tip of the cannula 1004 may desirably extend distally beyond, may be substantially flush with, or may be slightly proximally recessed relative to the distal tip of the catheter tube 1104 when the cannula 1004 is in the fully deployed state.
  • Relative lengths of, e.g., the reinforcement member 1030 (e.g. the proximal extension 1031 thereof) and the medial segment 1024 can be adjusted to ensure that a distal tip of the medial segment 1024 reaches a desired position relative to the proximal end of the catheter tube 1104 when the cannula 1004 is in the fully deployed state.
  • a distal tip or distal terminus 1050 of the medial segment 1024 mayremain proximally recessed, may be substantially flush with, or may enter into the proximal end of the catheter tube 1104 when the cannula 1004 is in the fully deployed state.
  • the medial segment 1024 may include an outer tube, or support tube (e.g., such as the support tube 1495 depicted in FIGS. 56A and 56B and described below).
  • at least an outer diameter of the support tube may be larger than an opening at the proximal end of the catheter tube 1104 (e.g., which correspond to an inner diameter of the catheter tube 1104).
  • the distal tip of the support tube which corresponds to the distal terminus 1050 of the medial segment 1024, can prevent the medial segment 1024 from entering into the catheter tube 1104.
  • use of a larger diameter support tube as just described can advantageously act as a primary defense against entry of the support tube into the catheter tube 1104.
  • this can act as a failsafe to ensure that the distal tip of the support tube does not enter the catheter tube 1104, such as, for example, where other dimensions of the access assembly 1000 also have been selected to prevent the support tube from entering the catheter tube 1104.
  • it may be desirable to avoid entry of the distal tip of the support tube, which otherwise could, in some arrangements, potentially deform, scrape, mar, and/or damage the catheter tube 1104 if permitted to enter therein.
  • the support tube may be sufficiently narrow to enter the catheter tube 1104.
  • the self-reinforced medial segment 1024 can be sufficiently strong and/or rigid to avoid bending, kinking, or buckling within the unfilled portion of the cavity 1173 of the extension hub 1180 and the adjoining unfilled cavity of the catheter hub 1106 as the cannula 1004 is distally advanced through this enlarged cavity region (i.e., enlarged as compared with the constriction provided by the reinforcement member 1030).
  • the selfreinforced medial segment 1024 can maintain alignment of the distal segment 1026 with a longitudinal axis of the catheter tube 1104 as the cannula 1004 is advanced distally. In other or further instances, the self-reinforced medial segment 1024 can reduce an unsupported length of the cannula 1004 within the extension hub 1180 and further, in some instances and/or in later stages of deployment, within the catheter hub 1106 as the cannula 1004 is advanced distally to the fully deployed state.
  • the cannula 1004 may not be moved to a fully deployed state.
  • the cannula 1104 may only be advanced from the initial or retracted position to a partially advanced position. This partially deployed, partially advanced, or intermediate state may be sufficient to achieve a desired position of the distal tip of the cannula 1004 beyond or within the distal end of the catheter tube 1104.
  • the access system 1000 may be usable with a variety of different base catheter systems that may have varying lengths of catheter tubes 1104, and the user may deploy the cannula 1004 by a different amount depending on which length of catheter tube is present.
  • FIG. 30 is a perspective view of another embodiment of an access system 1200 configured to be coupled with embodiments of a base catheter system, with the access system 1200 being shown in a retracted or undeployed state.
  • the access system 1200 may be particularly well-suited for use with a closed intravenous catheter system, such as, for example, a NEXIVATM closed catheter system.
  • Embodiments of the access system 1200 may resemble, e.g., embodiments of the access systems 300, 400, 500, 600 described above. Relevant disclosures regarding the various access systems 300, 400, 500, 600, 1200 thus may be applied interchangeably.
  • the access system 1200 can include a cannula 1204 of any suitable variety, including those disclosed elsewhere herein.
  • the cannula 1204 can be of any of the varieties discussed above, such as, for example, with respect to the cannuias 204, 1004, or below, such as, for example, with respect to the cannula 1404.
  • the access system 1200 includes a connector 1202 that is configured to couple with the proximal port 809 of embodiments of a closed intravenous catheter system 700 (see, e g., FIGS. 14 and 34).
  • the distal end of the connector 1202 can include a snapping or snap-fit arrangement.
  • the connector end 1202 includes a pair of opposing arms or flaps 1280 with inward protrusions 1281 to securely snap onto the proximal port 809, as shown in FIG. 32A (see also FIGS. 33 and 34).
  • FIG. 31 is a cross-sectional view of the access system 1200 in the retracted state.
  • FIG. 32A is a perspective view of an embodiment of a coupling member 1270 that is compatible with the access system 1200.
  • FIG. 32B is a cross- sectional view of the coupling member 1270.
  • the coupling member 1270 includes a reinforcing tube 1232 that extends or projects distally relative to a bottom, inner, recessed, or distally facing surface 1217 of the connector 1202, in manners such as previously discussed.
  • the proximal projection 1231 may instead be defined solely by a proximal extension of the reinforcing tube 1232, similar to an arrangement such as that depicted in FIG. 7. Stated otherwise, the reinforcing tube 1232 may define both a distal projection 1213 and the proximal extension 1231.
  • FIG. 33 is a cross-sectional view of a distal end of the access system 1200, while in the retracted or undeployed state, being advanced toward an embodiment of a closed intravenous catheter system 700 for coupling therewith.
  • FIG. 34 is a cross-sectional view of the distal end of the access system 1200, while in the retracted or undeployed state, coupled with the closed intravenous catheter system 700.
  • a distal tip of the reinforcing tube 1232 is advanced through the proximal septum 851 , but is proximally spaced from the valve 852 when the access system 1200 and the closed catheter system 700 are coupled together.
  • Advancement of a cannula portion of the access system 1200 through the reinforcing tube 1232, the valve 852, and ultimately the catheter tube 704 can proceed in manners such as previously discussed.
  • the reinforcing tube 1232 is advanced distally through the opening 855 of the retainer 853, then through the opening 854 of the proximal septum 851 .
  • These openings 855, 854 are aligned, or are colinear with, the sealable region 856 (and more particularly, the substantially linear needle tract through the sealable region 856).
  • the distal tip of the reinforcing tube 1232 is positioned at an interior of the proximal septum 851 , as shown in FIG. 34.
  • the cannula 1204 can be advanced distally, and the distal tip of the cannula 1204 can emerge from the reinforcing tube 1232 to move substantially rectilinearly through the distal end of the proximal septum 851 , then through the valve 852 (including through the sealable region 856 of the valve 856), then through the hub 806, then into and through the catheter tube 704.
  • the support member 1230 and/or the intrinsic support provided by the medial segment of the cannula 1204 can assist in the successful insertion of the cannula 1204 through the valve 852 without kinking or buckling of the distal segment of the cannula 1204.
  • the valve 852 may support the cannula 1204 as it is further advanced distally through the hub 806 and the catheter tube 704.
  • the valve 852 can provide lateral support that inhibits lateral deflections of the cannula 1204 in the region of contact between the sealable region 856 and the cannula 1204.
  • the cannula 1204 may resemble any of the disclosed varieties of the cannulas 204, 1004, or 1404 (which is described below).
  • the cannula 1204 includes a distal segment and a medial segment that resemble any variety of the distal and medial segments 226, 224 and/or 1026, 1024, respectively, discussed above, and/or the distal and medial segments 1426, 1424, respectively, discussed below. While only the distal segment is shown in FIG. 34, the presence and structure of medial segment can be understood from other drawings and disclosures herein.
  • the medial segment of the cannula 1204 includes two abutting tubes that are joined by heat-shrink tubing (see, e.g., FIG. 22).
  • the medial tube can be rigid, and may be formed of a metal — for example, the medial tube may comprise a stainless steel hypotube.
  • the medial segment of the cannula 1204 includes a flexible central tube that extends continuously along the distal and medial segments, but that is encompassed by a rigid tube along the length of the medial segment (see, e.g., FIGS. 56A and 56B).
  • the rigid tube may be formed of metal, such as a stainless steel hypotube.
  • the medial segment can have substantial radial strength so as to resist radial compression that might otherwise constrict or close a lumen through the tube.
  • the medial segment due to the presence of a rigid tube in the medial segment, can have a greater ability to maintain a fluid path that extends through a center of the medial segment in an open state, even under radial forces or stresses on the medial segment that would tend to constrict or close the fluid path if left unopposed.
  • the medial segment of the cannula 1204 when the cannula 1204 is in the deployed state, the medial segment of the cannula 1204 fully extends through the valve 852 of the closed intravenous catheter system 700.
  • the rigid tube that forms the medial segment or the support cannula that encompasses a flexible inner tube along the length of the medial segment passes through the valve 852 near the end of advancement of the cannula 1204 through the catheter tube 704. Due to the intrinsic rigidity of the rigid tube of the medial segment, the medial segment can prevent inward stresses provided to the cannula 1204 by the valve 852 that result from expansion of the sealable opening 856 from collapsing the medial segment.
  • the rigid tube can resist the compressive forces from the valve 852 to maintain the inner tube in a patent state.
  • the medial segment of the cannula 1204 can extend throughout an entirety of the sealable region 856 of the valve 852 to prevent the valve 852 from collapsing a flow path through the cannula 1204.
  • the reinforcement cannula 1332 is movable relative to a connector 1302 so as to advanced distally into this unsupported region of the catheter system 1100 and provide lateral support or reinforcement to a cannula 1304 as it is advanced distally through the hubs 1180, 1160 into the catheter tube 1104 of the catheter system 1100.
  • the cannula 1304 can be of any suitable construction, including those discussed elsewhere herein.
  • the cannula 1304 includes at least a distal segment and a medial segment formed in manners such as described elsewhere.
  • the medical segment may be intrinsically reinforced so as to resist or prevent kinking or buckling thereat as the cannula 1304 is advanced distally.
  • FIG. 35 is a perspective view of the access system 1300 in a retracted or undeployed state.
  • the access system 1300 can be particularly well-suited for use with open intravenous catheter systems, and may further be well-suited for use with extension sets coupled with such open intravenous catheter systems.
  • the movable reinforcement tube 1332 can be said to support the cannula 1304 along at least a portion of a length of the extension set, such as the extension set 1150, and/or through a length of a catheter hub to which the extension set is coupled, such as the catheter hub 1106.
  • FIG. 36 is a cross-sectional view of the access system 1300 in the retracted state.
  • FIG. 37A is a perspective view of an embodiment of the connector 1302, which includes a housing 1305 that is compatible with the access system 1300.
  • FIG. 37B is a perspective cross-sectional view of the housing of FIG. 37A.
  • the housing 1305 can define a proximal chamber 1390 and a distal chamber 1391.
  • the distal chamber 1391 can have a larger inner diameter than does the proximal chamber 1390.
  • the proximal chamber 1390 can be narrower so as to define a restricted region, whereas the distal chamber 1391 can be relatively larger to define an expanded region.
  • the proximal chamber 1390 includes a track 1364, similar to the anti-rotational track 1064 discussed previously.
  • the housing 1305 can include a distal protrusion 1313 similar to like numbered elements above. As discussed further below, the distal protrusion or projection 1313 can cooperate with or support a reinforcing member 1330 (see FIG. 36).
  • the distal projection 1313 can be fixed relative to the connector 1302.
  • the distal projection 1313 may be integrally formed with at least a distal end tube of the housing 1305.
  • the distal projection 1313 may define an inner diameter that is slightly larger than an outer diameter of the reinforcing tube 1332.
  • the reinforcing tube 1332 may be sized to slide through the distal projection 1313.
  • the distal projection 1313 may be viewed as a component of the reinforcing member 1330.
  • the reinforcing member 1330 can include both the distal projection 1313 and the reinforcing cannula 1332. In various embodiments, at least a portion of the reinforcing member 1330 is fixed relative to the housing 1305. In various embodiments, at least a portion of the reinforcing member 1330 is movable relative to the connector housing 1305.
  • each engagement protrusion 1394 can each include an engagement protrusion 1394 that is configured to interface with the catch 1393 in manners such as described below.
  • each engagement protrusion 1394 includes an engagement face 1395.
  • the engagement face 1395 may be a ramped or angled surface.
  • Each engagement face 1395 may be angled away from a central longitudinal axis of the follower 1360, in a proximal-to-distal direction.
  • the follower 1360 can Include an anti-rotation protrusion 1362, which can resemble the protrusion 1062 discussed above.
  • the anti-rotation protrusion 1362 may be configured to Interface with the track 1364 of the housing 1305 in manners such as previously described.
  • the follower 1360 may further include a proximal cavity 1371 and an opening 1373, which may be similar to the proximal cavity 1071 and the opening 1073 described above.
  • FIG. 39A is a perspective view of an embodiment of a reinforcement shuttle 1335 that includes the reinforcing tube 1332 and the catch 1393.
  • FIG. 39B is a cross-sectional view of the reinforcement shuttle 1335.
  • the engagement face 1339 can be angled away from a central longitudinal axis of the reinforcement shuttle 1335, in a proximal-to-distal direction.
  • the ramped engagement faces 1339, 1395 of the catch 1393 and the arms 1392 may be referred to as a ramped interface.
  • FIG. 40 is a cross-sectional view of a distal end of the access system 1300 when in the retracted state.
  • a distal tip of the cannula 1304 is recessed relative to a distal tip of the reinforcement cannula 1332, which is recessed relative to a distal tip of the distal projection 1313.
  • FIG. 41 is a cross-sectional view of a larger distal region of the access system 1300 when in the retracted state.
  • both the distal projection 1313 and the reinforcement shuttle 1335 which includes the reinforcement cannula 1332, can be components of the reinforcement member 1300. These components cooperate to reinforce the cannula 1304 as it is advanced from the retracted position, in manners such as discussed hereafter.
  • the medial segment 1324 comprises a rigid tube (e.g., formed of metal) that includes a distal tip that abuts a distal tip of the polymeric tube; the abutting ends of the tubes may be joined in any suitable fashion, such as via an overlying heat shrink tube. Other suitable arrangements are contemplated.
  • the distal and medial segments 1326, 1324 can meet at an interface 1352, which is positioned within the reinforcement tube 1332 in the illustrated retracted state of the access system 1300.
  • the catch 1393 and the distal ends of the arms 1392 of the follower 1360 which are coupled to the catch 1393, can be positioned within the proximal chamber 1390 of the housing 1305.
  • the narrow inner sidewall of the housing 1305 that defines the proximal chamber 1390 can constrain the arms 1392 so as to maintain the arms 1392 in a coupled state with the catch 1393.
  • the proximal chamber 1390 can be sized to maintain the angled faces 1395, 1339 of the arms 1392 and the catch 1335, respectively, engaged with each other. As further discussed below, this engagement of the angled faces may permit the arms 1392 of the follower 1360 to urge the catch 1393 distally as the cannula 1304, to which the follower 1360 is attached, is advanced distally.
  • the arms 1392 may be resiliently biased outwardly, or away from the central longitudinal axis, so as to spring outwardly when no longer constrained within the proximal chamber 1390.
  • the arms 1392 may be devoid of a bias.
  • the arms 1392 may be sufficiently flexible to be capable of being urged outwardly by the interaction of the angled faces 1395, 1339 when distal advancement of the reinforcement shuttle 1335 is inhibited and when the arms 1392 are not constrained within the proximal chamber 1390, as further discussed below.
  • FIG. 43 is a cross-sectional view of a generally proximal portion of the access system 1300 when in the retracted state.
  • the follower 1360 can be positioned at a proximal end of the housing 1305.
  • the anti-rotation protrusion 1362 can be positioned within the track 1364 of the housing 1305. Further details of the cannula 1304, which can resemble other cannulas previously discussed, are also shown.
  • FIG. 45 is a cross-sectional view of a generally intermediate region of the access system 1300 while in the coupled and retracted configuration depicted in FIG. 44.
  • FIG. 46 is a cross-sectional view of a distal portion of the access system 1300 while in the coupled and retracted state, which further depicts a proximal portion of the catheter assembly 1100.
  • the distal projection 1313 can extend a significant distance within the hub 1180.
  • a larger diameter region extends between the distal tip of the distal projection 1313 and the proximal tip of the catheter tube 1104 within the hubs 1180, 1106. This is the region that is bridged by the reinforcement tube 1332 as the access system 1300 is deployed, as further discussed below.
  • FIG. 47 is a cross-sectional view of the access system 1300 coupled with the base catheter assembly 1100 while in a partially deployed state, or stated otherwise, while in an intermediate stage or state of deployment.
  • the cannula 1304 has been advanced distally through a first distance, which in turn, has advanced the follower 1360 distally through the housing 1305 by the same distance.
  • FIG. 48 is a cross-sectional view of an intermediate region of the access system 1300 while in the partially deployed state.
  • the arms 1392 In being advanced to the illustrated orientation, the arms 1392 have been and remain in a low-profile state, as constrained by the proximal chamber 1390. This maintains contact between the ramped surfaces 1395, 1339.
  • the ramped surfaces 1395 pushes against the ramped surface 1339 to advance the reinforcement shuttle 1335 distally in unison with distal advancement of the follower 1360 and the cannula 1304.
  • the distal ends of the arms 1392 have advanced distally past the end of the proximal chamber 1390 of the housing 1305 and have entered the enlarged cavity of the distal chamber 1391.
  • the arms 1392 are not resiliently outwardly biased, and thus do not automatically expand to an enlarged state when no longer constrained in a low-profile orientation.
  • a substantial proximal length of the arms 1392 remains positioned within the proximal chamber 1390 in the constrained state, such that the distal tips of the arms 1392 will generally remain in the low-profile state, even when in the enlarged distal chamber 1391 , unless and until they are urged outwardly.
  • the distal ends of the arms 1392 are at a position within the distal chamber 1391 at which they may be allowed to be urged radially our laterally outwardly to an expanded profile.
  • FIG. 49 is a cross-sectional view of a distal end of the access system 1300 and a proximal portion of the base catheter assembly 1100 while the access system 1300 is in the partially deployed state. At this point, a distal tip of the reinforcement tube 1332 has come into contact with the proximal tip 1107 of the catheter tube
  • the distal end of the cannula 1304 remains within the reinforcement tube 1332 until there is relative movement between the follower 1360 and the reinforcement shuttle 1335 (FIG. 48).
  • FIG. 50 is a cross-sectional view of the access system 1300 coupled with the base catheter assembly 1100 while in fully deployed state.
  • FIG. 51 is a cross- sectional view of an intermediate region of the access system 1300 while in the fully deployed state.
  • the reinforcement shuttle 1335 remains in the same configuration depicted in FIGS. 47-49. That is, the distal tip of the reinforcement tube 1330 remains abutted against the proximal tip 1107 of the catheter tube1104 (FIG. 49).
  • the reinforcement tube 1330 may additionally or alternatively be sized to abut against an inner surface of the catheter hub 1106 (FIG. 49). As the cannula 1304 is advanced distally relative to the orientation shown in FIGS.
  • the follower 1360 moves distally in unison with the cannula 1304, to which it is attached.
  • the reinforcement tube 1104 and the catch 1393 that is attached thereto remain in a fixed position relative to the housing 1305 due to interference between the reinforcement cannula 1332 and the catheter tube 1104.
  • the ramped or angled surfaces 1395 of the arms 1392 press against the ramped or angled surface 1339 of the immobilized catch 1393.
  • the angled surfaces 1395 interact with the angled surface 1339 to urge the distal ends of the arms 1392 outwardly.
  • the distal chamber 1391 of the housing 1305 provides sufficient clearance to permit the deflected ends of the arms 1392 to pass over the catch 1393 and resiliently return to the straightened state shown in FIG. 51.
  • the follower 1360 moves in unison with the cannula 1304 and the arms 1392 of the follower 1360 pass over or by or beside the outer surface of the catch 1393.
  • various parameters may be adjusted to permit the arms 1392 to disengage from and move distally relative to the catch 1393 in manners such as just described.
  • a stiffness of the arms 1392 may be selected to ensure that disengagement only occurs once threshold level of resistance to distal movement of the reinforcement tube 1332 is experienced.
  • a relative orientation of the proximal and distal chambers 1390, 1391 of the housing 1305 may also or alternatively be adjusted.
  • the access system 1300 may be configured for use with a variety of different base catheter systems (with and/or without extension sets) that define a variety of different lengths through which the reinforcement tube 1332 passes before encountering resistance to forward advancement. Certain embodiments may permit the arms 1392 to remain engaged with the catch 1393 until resistance is met at any of these various lengths and to thereafter disengage from the catch 1393.
  • FIG. 52 is a cross-sectional view of a generally distal portion of the access system 1300 and a proximal portion of the base catheter assembly 1100 while the access system is in the fully deployed state.
  • the distal tip of the reinforcement cannula 1332 remains engaged with and immobilized by the proximal tip 1107 of the catheter tube 1104 throughout distal advancement of the cannula 1304 past the intermediate position depicted in FIGS. 47-49.
  • the cannula 1304 passes through the immobilized reinforcement cannula 1332 and is reinforced thereby in the event that resistance to distal movement of the cannula 1304 is encountered, such as at a bend or kink in the catheter tube 1304.
  • FIG 53 is a cross-sectional view of distal ends of the access system 1300 and the base catheter assembly 1100 while the access system 1300 is in the fully deployed state.
  • the cannula 1304 extends past the distal tip of the catheter tube 1104.
  • FIG. 54 is a perspective view of another embodiment of an access system 1400
  • FIG. 55 is a cross-sectional view of the access system 1400.
  • the access system 1400 is shown in both drawings in a retracted state.
  • the access system 1400 includes a removable sterility cap 1494 that is coupled to a connector 1402.
  • the cap 1494 can be included with the packaged access system 1400 and removed prior to use.
  • the illustrated connector 1402 includes a snap-fit arrangement, such as previously disclosed, for example, with respect to the access system 1200.
  • the access system 1400 may resemble the access system 1200 in many respects, and may be particularly suitable for use with a closed intravenous catheter system.
  • the cannula 1204 of the embodiment of the access system 1200 illustrated in FIGS. 30-34 includes two abutting tubes that are joined by heat-shrink tubing.
  • other cannula configurations are disclosed with respect to the access system 1200, including a cannula that includes a continuous polymeric tube and a support tube that encompasses at least an intermediate region of the polymeric tube.
  • the cannula 1204 of the access system 1400 is of the latter configuration.
  • the cannula 1404 can include a proximal segment 1422, a medial segment 1424, and a distal segment 1426.
  • the cannula 1404 Includes a central tube 1496 that defines the distal segment 1426.
  • the central tube 1496 extends continuously through the medial segment 1424.
  • a proximal end of the central tube 1496 is positioned in a portion of the proximal segment 1422.
  • the proximal segment 1422 further includes a proximal tube 1422 of any suitable form, such as described previously herein.
  • the central tube 1496 maybe coupled with the proximal tube 1422 in any suitable manner, such as by a press fit, adhesive, etc. At least the proximal tube 1422 may be fixedly secured to a follower 1460.
  • the central tube 1496 may be formed of any suitable material, such as disclosed with respect to other embodiments (e.g., a polymeric material).
  • the central tube 1496 may be flexible. Embodiments of the central tube 1496 can be laterally flexible while having sufficient columnar or axial strength or rigidity to navigate or negotiate tortuous paths through a catheter tube and/or sufficient radial strength to remain patent when within such tortuous paths.
  • the media! segment 1424 can further include a support tube 1495 that encompasses, encircles, sheathes, covers, overlays, etc. an intermediate portion of the central tube 1496.
  • the support tube 1495 may be relatively rigid, as previously discussed.
  • the support tube 1495 may be metallic, such as a stainless steel hypotube.
  • the support tube 1495 is fixedly secured to at least a proximal end of the central tube 1496. In some embodiments, the support tube 1495 is adhered or otherwise secured to the central tube 1496 only at a proximal end of the support tube 1495. In other embodiments, the support tube
  • the support tube 1495 may have an inner diameter that is only slightly, narrowly, marginally, or minimally larger than; is approximately the same as; conforms or substantially conforms with; and/or substantially inhibits, limits, and/or prevents lateral movements of an outer diameter of the central tube 1496.
  • the support tube 1495 can be in a fixed longitudinal relationship with the central tube
  • the inner diameter of the support tube 1495 is no greater than 5, 10, 15, 20, 25, or 30 percent larger than the outer diameter of the central tube 1496.
  • a distal tip or distal edge of the support tube 1495 can correspond to a distal terminus 1450 of the medial segment 1424.
  • the central tube 1496 may extend continuously through the distal terminus 1450, the medial and distal segments 1424, 1426 may still be said to meet at an interface 1452 at the distal terminus 1450 of the medial segment 1424.
  • the interface 1452 may be positioned within a reinforcement tube 1432 when the cannula 1404 is in the retracted state, as shown in FIG. 56A. As the cannula is advanced distally, the support tube 1495 moves in tandem with the central tube 1496 that it encompasses and slides distally within the reinforcement tube 1432.
  • the access system 1400 can be particularly well suited for use with closed catheter systems. The access system 1400 may be coupled and used with the closed catheter system 700 in a manner such as described above with respect to the access system 1200 in FIGS. 33 and 34.
  • FIGS. 57 and 58 depict another embodiment of an access system 1500.
  • the access system 1500 can be particularly well suited for use with an open catheter system, whether with or without an extension set.
  • the access system 1500 can include a cannula 1504 that is substantially the same as the cannula 1404 just discussed with respect to the access system 1400.
  • the cannula 1404 can include a central tube and a support member that encompasses the central tube.
  • Other arrangements for the cannula 1504, including those discussed elsewhere herein, are also contemplated.
  • the access system 1500 can further include a sealing member 1600 coupled with a reinforcement tube 1532 and the cannula 1504.
  • An open catheter system may not include a sealing member or valve that could seal against the cannula 1504 during use.
  • the sealing member 1600 can prevent blood that might pass proximally through an annular space between the reinforcement tube 1532 and the cannula 1504 from egressing from a proximal end of the reinforcement tube 1532 and into a housing of the access system 1500.
  • FIG. 59 provides a more detailed view of in internal portion of the access assembly 1500 that includes the sealing member 1600.
  • the sealing member 1600 can be fixedly secured to a proximal end of the reinforcement tube 1532.
  • the proximal end of the sealing member can include a proximal opening 1602 through which a support tube 1595 of the cannula 1504 passes.
  • the sealing member 1600 can form a static seal with the reinforcement tube 1532 and can form a dynamic seal with the support tube 1595. Stated otherwise, the sealing member 1600 can be in a fixed relation relative to the reinforcement tube 1532, yet can permit movement of the support tube 1595 relative thereto, while the sealing member 1600 maintains a fluid tight seal with each of the reinforcement tube 1532 and the support tube 1595.
  • the sealing member 1600 can prevent blood from egressing from the support tube 1595 and through the proximal opening 1602.
  • FIG. 60 depicts another embodiment of a sealing member 1700, which can resemble the sealing member 1600 in many respects.
  • the sealing member 1700 includes a proximal opening 1702 and a strain-relief region 1704 at a proximal end of the sealing member 1700.
  • a distal end of an internal cavity 1706 defined by the sealing member 1700 can have a reduced diameter D1 at which the sealing member 1700 tightly grips the reinforcing member 1532 and forms a static, fluid-tight seal therewith.
  • a proximal end of the internal cavity 1704 can have an undercut or expanded region defining an expanded diameter D2.
  • FIG. 61 is a perspective view of another embodiment of an access system 1800 in a retracted state.
  • FIG. 62 is a cross-sectional view of the access system 1800 in the retracted state.
  • the access system 1800 includes a tab 1898 that extends through a longitudinal track 1899 in the housing element.
  • the tab 1898 is attached to an internal coupler 1861 , that can resemble previously described followers in general configuration, but can differ significantly therefrom in its connection to the externally positioned tab 1898.
  • the internal coupler 1861 may alternatively be referred to as a follower, although it differs from other followers herein described in at least one significant respect.
  • the internal coupler 1861 may additionally move in response to forces applied to the tab 1898. Regardless, the internal coupler 1861 does not instigate or otherwise cause movement of a cannula 1804 to which it is attached. Movements of the internal coupler 1861 are purely passive and in response to either movement of the cannula 1804 or movement of the tab 1898.
  • the internal coupler 1861 can be connected with portions of a cannula 1804, such that the cannula 1804 can be moved in response to movement of the tab 1898.
  • the tab 1898 can be used to move the internal coupler 1861 forwardly and rearwardly along the designated track 1898 and thereby advance and retract the cannula 1804.
  • FIG. 63 is a perspective cross-sectional view of another embodiment of an access system 1900 that includes a deployable cannula 1904.
  • FIG. 64 is a cross- sectional view of a generally distal portion of the access system 1900.
  • the cannula 1904 includes a unitary central tube 1996 (e.g., formed of a polymeric material) without any support tube attached thereto.
  • the central tube 1996 is attached at its proximal end to a proximal 1923.
  • the access system 1900 includes a reinforcement member 1930 at a distal end thereof that is defined by a connection member 1970.
  • Methods of using embodiments of access systems are discussed above. Certain methods can include placing a base catheter system in the vasculature of a patient.
  • Other or further methods can include coupling an access system with a preplaced base catheter system.
  • the base catheter system may be placed in one or more of a dorsal arch of a hand, a forearm, or an antecubital fossa position on a patient.
  • the access systems may include supported cannula that are capable of use with base catheter tubes that may define significantly tortuous paths.
  • the base catheter system may be placed on the patient in a typical fashion that does not involve the use of special spacing or orientation apparatus.
  • some embodiments of access systems may be used with base catheter systems that have been taped down to the skin of the patient or secured to the skin of the patient with a standard flat dressing. There may be no spacing element present, such as a wedge-shaped device configured to provide an entry angle for the access system. That is, the access systems may be usable through a tortuous region defined by a base catheter system that is taped or otherwise secured directly to the skin of the patient.
  • Example X to Example Y means Example X through Example Y, and thus includes the endpoints of the recited range of examples.
  • Example 1 An access system comprising: a connector configured to couple with a catheter assembly that comprises a catheter tube configured to be positioned in a blood vessel of a patient; a reinforcement member coupled with the connector; and a cannula movable relative to the reinforcement member from a retracted position in which at least a portion of the cannula is within the reinforcement member to an advanced position, the cannula comprising: a first segment at a distal end of the cannula that defines a distal tip of the cannula; and a second segment that is relatively stiffer than the first segment and extends proximally from the first segment, the second segment comprising a distal terminus that is configured to be within the reinforcement member when the distal tip of the cannula is first positioned distal of and external to the reinforcement member as the cannula is transitioned from the retracted position to the advanced position, wherein, when the connector and the catheter assembly are in a coupled state, at least a portion of the first segment of the cann
  • Example 2 The access system of Example 1 , wherein the catheter assembly is configured to be preplaced in the patient such that the catheter tube is positioned in the blood vessel of the patient prior to coupling of the connector of the access system with the catheter assembly.
  • Example 3 The access system of Example 1 or Example 2, wherein, when the catheter tube of the catheter assembly is positioned in the blood vessel of the patient and when the connector of the access system and the catheter assembly are in the coupled state, advancement of the cannula to the advanced position enables fluid communication directly between the cannula and the blood vessel.
  • Example 4 The access system of any one of Example 1 to Example 3, wherein when the cannula is in the advanced position, the distal tip of the cannula extends distally past a distal tip of the catheter tube.
  • Example 5 The access system of any one of Example 1 to Example 3, wherein when the cannula is in the advanced position, the distal tip of the cannula is positioned within the catheter tube at or proximate to a distal tip of the catheter tube.
  • Example 6 The access system of any one of Example 1 to Example 5, wherein when the cannula is in the advanced position, said at least a portion of the cannula is positioned outside of and distal to a distal tip of the reinforcement member.
  • Example 7 The access system of any one of Example 1 to Example 6, wherein the second segment of the cannula is relatively harder than the first segment of the cannula.
  • Example 8 The access system of any one of Example 1 to Example 7, wherein the second segment of the cannula comprises a flexible and/or polymeric tube and a support member that is stiffer than and encompasses at least a portion of the flexible and/or polymeric tube.
  • Example 9 The access system of Example 8, wherein at least a distal end of the support member is encompassed by the reinforcement member when the cannula is in the retracted position.
  • Example 10 The access system of Example 8 or Example 9, wherein at least an intermediate portion of the flexible and/or polymeric tube that continuously extends along at least a portion of each of the first and second segments is encompassed by one or more of the reinforcement member and the support member along a full length of the intermediate portion when the cannula is in the retracted position.
  • Example 11 The access system of any one of Example 8 to Example 10, wherein the support member advances distally through the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.
  • Example 12 The access system of any one of Example 8 to Example 11 , wherein the distal terminus comprises a distal tip of the support member.
  • Example 13 The access system of any one of Example 8 to Example 12, wherein the flexible and/or polymeric tube fits snugly within the support member.
  • Example 14 The access system of any one of Example 8 to Example 13, wherein the support member is fixed relative to the flexible and/or polymeric tube.
  • Example 15 The access system of Example 14, wherein the support member is adhered to the flexible and/or polymeric tube.
  • Example 16 The access system of any one of Example 8 to Example 15, wherein the flexible and/or polymeric tube extends through a full length of the support member.
  • Example 17 The access system of any one of Example 8 to Example 16, wherein the support member extends along a full length of the second segment.
  • Example 18 The access system of any one of Example 8 to Example 17, wherein the cannula further comprises a third segment that extends proximally from the second segment.
  • Example 19 The access system of Example 18, wherein the third segment comprises a proximal tube having an outer diameter that is larger than an outer diameter of the flexible and/or polymeric tube.
  • Example 20 The access system of Example 18 or Example 19, wherein the flexible and/or polymeric tube is fixedly secured to the proximal tube.
  • Example 21 The access system of any one of Example 18 to Example 20, further comprising a follower attached to each of the second and third segments.
  • Example 22 The access system of any one of Example 8 to Example 20, wherein the first segment comprises a portion of the flexible and/or polymeric tube.
  • Example 23 The access system of Example 22, wherein the first segment is formed exclusively from the flexible and/or polymeric tube.
  • Example 24 The access system of Example 22, wherein the flexible and/or polymeric tube is formed of a unitary piece of material that extends continuously from the first segment to the second segment.
  • Example 25 The access system of any one of Example 8 to Example 24, wherein the flexible and/or polymeric tube is formed of polyimide.
  • Example 26 The access system of any one of Example 8 to Example 25, wherein the support member comprises a support tube that circumscribes an outer surface of the flexible and/or polymeric tube.
  • Example 27 The access system of Example 26, wherein the support tube comprises a metallic material
  • Example 28 The access system of Example 27, wherein the support tube is formed of stainless steel.
  • Example 29 The access system of any one of Example 8 to Example 28, wherein the support member is sized to slide through at least a portion of the reinforcement member as the cannula is transitioned from the retracted position to the advanced position.
  • Example 32 The access system of Example 30 or Example 31 , wherein the sealing member is attached to a proximal end of the reinforcement member.
  • Example 33 The access system of any one of Example 30 to Example 32 wherein the sealing member encompasses a proximal tip of the reinforcement member.
  • Example 34 The access system of any one of Example 8 to Example 33, wherein the reinforcement member defines a lumen that defines an inner diameter that is no greater than 20 percent larger than an outer diameter of the support member.
  • Example 35 The access system of any one of Example 8 to Example 34, wherein the support member prevents kinking of the flexible and/or polymeric tube when the first segment encounters force resistive to distal advancement of the distal tip of the cannula by preventing lateral movement of the flexible and/or polymeric tube within the support member in an amount that otherwise would be sufficient to kink the flexible and/or polymeric tube.
  • Example 36 The access system of any one of Example 1 to Example 7, wherein the first segment comprises a first tube that comprises a first end face, the second segment comprises a second tube that comprises a second end face, and the first and second end faces abut one another at an interface positioned at the distal terminus of the second segment.
  • Example 37 The access system of Example 36, wherein each of the first and second end faces is transversely oriented relative to a longitudinal axis of the cannula.
  • Example 38 The access system of Example 36 or Example 37, wherein the second tube is stiffer than the first tube.
  • Example 39 The access system of Example 38, wherein the second tube is formed of a metallic material
  • Example 40 The access system of Example 39, wherein the second tube is formed of stainless steel.
  • Example 41 The access system of any one of Example 36 to Example 40, wherein the first tube is formed of a polymeric material.
  • Example 42 The access system of any one of Example 36 to Example 41 , further comprising a tie layer extending over the interface and at least a portion of each of the first and second tubes of the first and second segments, respectively, to attach the first and second tubes together or to reinforce an attachment between the first and second tubes.
  • Example 44 The access system of Example 42 or Example 43, wherein an outer diameter of the tie layer is substantially constant along a transition region that includes a proximal end of the first segment, the interface, and a distal end of the second segment.
  • Example 45 The access system any one of Example 42 to Example 44, wherein the tie layer comprises a tubular member that defines a thickness that is no less than five times smaller than a thickness of the first tube.
  • Example 46 The access system of any one of Example 42 to Example 45, wherein the tie layer comprises a tube formed of heat shrinkable material.
  • Example 48 The access system of any one of Example 42 to Example 47, wherein a distal tip of the tie layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the tie layer is configured to contact an internal surface of the catheter tube to delimit proximal movement of the cannula relative to the catheter tube.
  • Example 49 The access system of any one of Example 42 to Example 48, wherein a distal tip of the tie layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the tie layer is configured to contact an internal surface of the catheter tube to provide tactile feedback to a user regarding a position of the cannula relative to the catheter tube.
  • Example 50 The access system of any one of Example 1 to Example 49, wherein the reinforcement member prevents kinking of the first segment when the first segment encounters force resistive to distal advancement of the distal tip of the cannula by preventing lateral movement of the first segment within the reinforcement member in an amount that otherwise would be sufficient to kink the first segment.
  • Example 51 The access system of any one of Example 1 to Example 50, wherein an inner diameter of the first segment is no greater than an inner diameter of the second segment.
  • Example 54 The access system of Example 53, wherein the inner diameter of the lumen is constant along a tubular region that extends along at least a portion of a full length of the reinforcement member.
  • Example 55 The access system of Example 54, wherein the tubular region extends to a distal tip of the reinforcement member.
  • Example 56 The access system of Example 54 or Example 55, wherein the tubular region extends along at least a majority of the full length of the reinforcement member.
  • Example 57 The access system of any one of Example 1 to Example 56, wherein the reinforcement member comprises a stainless steel tube.
  • Example 58 The access system of Example 57, wherein the reinforcement member further comprises a polymeric material overmolded onto the stainless steel tube.
  • Example 59 The access system of any one of Example 1 to Example 56, wherein the connector and the reinforcement member are integrally formed of a unitary piece of material.
  • Example 60 The access system of Example 59, wherein the unitary piece of material is polymeric.
  • Example 61 The access system of any one of Example 1 to Example 60, wherein the first segment is shorter than the reinforcement member.
  • Example 62 The access system of any one of Example 1 to Example 60, wherein the first segment is longer than the reinforcement member.
  • Example 63 The access system of any one of Example 1 to Example 62, wherein the distal tip of the cannula is positioned within the reinforcement member when the cannula is in the retracted position, such that the distal tip of the cannula is first positioned distal of and external to the reinforcement member only after the cannula has been moved from the retracted position.
  • Example 64 The access system of any one of Example 1 to Example 62, wherein the distal tip of the cannula is first positioned distal of and external to the reinforcement member when the cannula is in the retracted position.
  • Example 65 The access system of any one of Example 1 to Example 64, wherein the distal terminus of the second segment of the cannula is within the reinforcement member when the cannula is in the retracted position.
  • Example 66 The access system of any one of Example 1 to Example 65, wherein the distal terminus of the second segment of the cannula is distal to a distal edge of the reinforcement member when the cannula is in the advanced position.
  • Example 67 The access system of any one of Example 1 to Example 66, wherein the catheter assembly comprises an extension set that comprises a hub, wherein the distal terminus of the second segment of the cannula is positioned within the hub when the cannula is in the advanced position.
  • Example 69 The access system of any one of Example 1 to Example 65, wherein the distal terminus of the second segment of the cannula is within the reinforcement member when the cannula is in the advanced position.
  • Example 70 The access system of any one of Example 1 to Example 65, wherein the distal terminus of the second segment of the cannula is within the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.
  • Example 71 The access system of any one of Example 1 to Example 70, further comprising a sheath coupled to the connector, wherein the cannula extends through at least a portion of the sheath, the cannula being movable relative to the sheath from the retracted position to the advanced position.
  • Example 72 The access system of Example 71 , wherein at least a portion of the sheath and at least a portion of the connector are integrally formed of a unitary piece of material.
  • Example 73 The access system of Example 71 or Example 72, wherein, when the cannula is in each of the retracted and advanced positions, at least some portion of the cannula is positioned within the sheath.
  • Example 74 The access system of any one of Example 71 to Example 73, wherein at least some portion of the cannula is positioned within the sheath throughout movement of the cannula from the retracted position to the advanced position.
  • Example 75 The access system of any one of Example 71 to Example 74, wherein the sheath comprises a tube having a proximal end and a distal end, and wherein the cannula extends through at least the proximal end of the sheath when in the retracted position and extends through at least the distal end of the sheath when in the advanced position.
  • Example 76 The access system of any one of Example 71 to Example 75, further comprising a follower fixedly attached to the cannula and positioned within the sheath, wherein the follower moves in unison with the cannula as the cannula is moved from the retracted position to the advanced position.
  • Example 77 The access system of Example 76, wherein the follower cooperates with the sheath to delimit proximal movement of the cannula relative to the sheath.
  • Example 78 The access system of Example 76 or Example 77, wherein the follower and the sheath comprise a rotational alignment mechanism by which a rotational orientation of the cannula is maintained relative to the sheath.
  • Example 79 The access system of Example 78, wherein the rotational alignment mechanism comprises a protrusion positioned within a groove, wherein the sheath defines one of the protrusion and the groove and the follower defines the other of the protrusion and the groove.
  • Example 80 The access system of any one of Example 76 to Example 79, wherein: the reinforcement member comprises a reinforcing tube that is movable relative to the connector; the follower is coupled to the reinforcing tube while the cannula is in the retracted position such that the follower and the reinforcing tube move distally in tandem with the cannula throughout movement of the cannula from the retracted position to an intermediate position that is proximal of the advanced position; and the follower is configured to decouple from the reinforcing tube as the cannula is moved distally past the intermediate position.
  • Example 81 The access system of Example 80, wherein when the follower decouples from the reinforcing tube, the follower and the cannula are permitted to move distally relative to the reinforcing tube while the reinforcing tube remains fixed relative to the connector.
  • Example 82 The access system of Example 80 or Example 81 , further comprising a catch fixedly attached to the reinforcing tube, wherein the follower comprises a plurality of arms that grasp the catch throughout movement of the cannula from the retracted position to the intermediate position and release the catch as the cannula is moved distally past the intermediate position.
  • Example 83 The access system of Example 82, wherein: the sheath comprises a first chamber that defines a first diameter and a second chamber positioned distal of the first chamber that defines a second diameter larger than the first diameter; the first chamber of the sheath Is sized to constrain at least distal ends of the plurality of arms from flexing outwardly while the distal ends are positioned in the first chamber such that the arms engage the catch while in the first chamber; and the second chamber of the sheath is sized to permit the distal ends of the plurality of arms to flex outwardly to disengage from the catch and to move distally past the catch.
  • Example 84 The access system of Example 83, wherein a proximal end of the second chamber is proximal of the intermediate position.
  • Example 85 The access system of Example 83 or Example 84, wherein the plurality of arms are outwardly biased such that the distal ends of the plurality of arms automatically flex outwardly and disengage from the catch when advanced through the second chamber of the sheath.
  • Example 87 The access system of any one of Example 71 to Example 86, further comprising an actuator attached to the cannula, wherein at least a portion of the actuator is accessible external to the sheath so as to be manipulated to move the cannula between the advanced and retracted positions.
  • Example 88 The access system of Example 87, wherein the sheath comprises a longitudinally extending track, and wherein a portion of the actuator extends through the track.
  • Example 89 The access system of any one of Example 71 to Example 88, wherein the cannula is moved from the retracted position to the advanced position by directly contacting the cannula.
  • Example 90 The access system of any one of Example 1 to Example 89, wherein the connector comprises a threaded region that is configured to cooperate with a complementary portion of the catheter assembly to securely couple the connector with the catheter assembly.
  • Example 92 The access system of any one of Example 1 to Example 91 , wherein the cannula comprises a further connector at a proximal end thereof for connecting the cannula to a fluid transfer device.
  • Example 93 The access system of Example 92, wherein the fluid transfer device comprises a blood collection unit.
  • Example 94 The access system of Example 92 of Example 93, wherein the further connector comprises a luer fitting.
  • Example 95 The access system of any one of Example 1 to Example 94, wherein the cannula is further movable from the advanced position to the retracted position.
  • Example 96 The access system of any one of Example 1 to Example 95, wherein when the cannula is in the advanced position, a length of the cannula extends through the reinforcement member.
  • Example 97 The access system of Example 96, wherein the second segment of the cannula defines at least a portion of the length of the cannula that extends through the reinforcement member when the cannula is in the advanced position.
  • Example 102 The access system of any one of Example 99 to Example 101 , wherein the projection extends distally past a distal end of the connector.
  • Example 104 The access system of any one of Example 99 to Example 104, wherein the catheter assembly further comprises a valve positioned distal to the septum.
  • Example 107 The access system of any one of Example 104 to Example 106, wherein, when the connector is coupled with the catheter assembly, a portion of the reinforcement member extends through the septum.
  • Example 108. The access system of any one of Example 104 to Example 107, wherein, when the connector is coupled with the catheter assembly, the reinforcement member aims the cannula toward a sealable opening of the valve such that the distal tip of the cannula is advanced through the sealable opening of the valve as the cannula is moved from the retracted position to the advanced position.
  • Example 109 The access system of Example 108, wherein the sealable opening is substantially centered relative to the valve, and wherein, when the connector is coupled with the catheter assembly, the reinforcement member is substantially- centered so as to be aligned with the sealable opening.
  • Example 110 The access system of any one of Example 104 to Example 109, wherein, when the cannula is in the advanced position, at least a portion of the second segment of the cannula extends through the valve.
  • Example 111 The access system of Example 110, wherein, when the cannula is in the advanced position, the distal terminus of the second segment of the cannula is distal to the valve.
  • Example 112 The access system of any one of Example 99 to Example 111 , wherein the catheter assembly further comprises a removable piercing member that extends through the septum and through the catheter tube to assist in positioning the catheter tube in the blood vessel of the patient, and wherein the piercing member is configured to be removed from the catheter assembly prior to coupling the connector of the access system with the catheter assembly.
  • Example 113 The access system of Example 112, wherein the removable piercing member further extends through the valve when extending through the septum and through the catheter tube.
  • Example 114 The access system of any one of Example 1 to Example 97, wherein the catheter assembly is a closed intravenous catheter system.
  • Example 115 The access system of Example 114, wherein the closed intravenous catheter system comprises an integrated side port through which fluid may be transferred to or from the catheter tube.
  • Example 116 The access system of any one of Example 1 to Example 97, wherein the catheter assembly is an open intravenous catheter system.
  • Example 117 The access system of any one of Example 1 to Example 116, wherein an entirety of the reinforcement member is external to the catheter tube when the connector is coupled with the catheter assembly.
  • Example 118 The access system of Example 117, wherein the entirety of the reinforcement member remains external to the catheter tube throughout movement of the cannula from the retracted position to the advanced position.
  • Example 119 The access system of any one of Example 1 to Example 118, wherein a distal tip of the reinforcement member is proximal to a proximal tip the catheter tube when the connector is coupled with the catheter assembly.
  • Example 120 The access system of Example 119, wherein the distal tip of the reinforcement member remains proximal to the proximal tip of the catheter tube throughout movement of the cannula from the retracted position to the advanced position.
  • Example 121 The access system of Example 1 , wherein the reinforcement member is fixed relative to the connector.
  • Example 122 The access system of Example 1 , wherein the reinforcement member comprises a first metallic hypotube, and wherein the second segment comprises a second metallic hypotube sized to translate within the first metallic hypotube.
  • Example 123 The access system of Example 122, wherein each of the first and second segments is at least partially defined by a unitary polymeric tube, and wherein the second metallic hypotube encompasses a portion of the polymeric tube.
  • Example 125 The access system of any one of Example 1 to Example 124, further comprising the catheter assembly.
  • Example 126 A kit comprising: an access system according to any one of Example 1 to Example 125; and instructions for using the kit, the instructions comprising directions to: couple the connector to the catheter assembly while the catheter tube of the catheter assembly is positioned in the blood vessel of the patient; and advance the cannula from the retracted position to the advanced position.
  • Example 127 The kit of Example 126, wherein the instructions for using the kit further comprise directions to: couple a fluid transfer device to the cannula; and draw blood from the blood vessel through the cannula and into the fluid transfer device.
  • Example 128 A method of using the access system of any one of Example 1 to Example 125, the method comprising: coupling the connector to the catheter assembly while the catheter tube of the catheter assembly is positioned in the blood vessel of the patient; and advancing the cannula from the retracted position to the advanced position.
  • the cannula comprises a flexible tube (whether or not the tube is polymeric), while in other or further embodiments, the cannula comprises a polymeric tube, which can have properties such as described in the present disclosure.
  • Example 130 By flexible and/or polymeric tube, it is meant that in some embodiments, the cannula comprises a flexible tube (whether or not the tube is polymeric), while in other or further embodiments, the cannula comprises a polymeric tube, which can have properties such as described in the present disclosure. Example 130.
  • Example 136 The access system of any one of Example 129 to Example 134, wherein the distal tip of the flexible and/or polymeric tube is first positioned distal of and external to the reinforcement member when the cannula is in the retracted position.
  • Example 137 The access system of any one of Example 129 to Example 136, wherein the distal edge of the support tube is within the reinforcement member when the cannula is in the retracted position.
  • Example 139 The access system of any one of Example 129 to Example 138, wherein the catheter assembly comprises an extension set that comprises a hub, wherein the distal edge of the support tube is positioned within the hub when the cannula is in the advanced position.
  • Example 141 The access system of any one of Example 129 to Example 137, wherein the distal edge of the support tube is within the reinforcement member when the cannula is in the advanced position.
  • Example 142 The access system of Example 129 or Example 141 , wherein the distal edge of the support tube is within the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.
  • Example 143 The access system of any one of Example 129 to Example 142, further comprising a sheath coupled to the connector, wherein the cannula extends through at least a portion of the sheath, the cannula being movable relative to the sheath from the retracted position to the advanced position.
  • Example 144 The access system of Example 143, wherein at least a portion of the sheath and at least a portion of the connector are integrally formed of a unitary piece of material.
  • Example 146 The access system of any one of Example 143 to Example 145, wherein at least some portion of the cannula is positioned within the sheath throughout movement of the cannula from the retracted position to the advanced position.
  • Example 147 The access system of any one of Example 143 to Example 146, wherein the sheath comprises a tube having a proximal end and a distal end, and wherein the cannula extends through at least the proximal end of the sheath when in the retracted position and extends through at least the distal end of the sheath when in the advanced position.
  • Example 148 The access system of any one of Example 143 to Example 147, further comprising a follower fixedly attached to the cannula and positioned within the sheath, wherein the follower moves in unison with the cannula as the cannula is moved from the retracted position to the advanced position.
  • Example 150 The access system of Example 148 or Example 149, wherein the follower and the sheath comprise a rotational alignment mechanism by which a rotational orientation of the cannula is maintained relative to the sheath.
  • Example 151 The access system of Example 150, wherein the rotational alignment mechanism comprises a protrusion positioned within a groove, wherein the sheath defines one of the protrusion and the groove and the follower defines the other of the protrusion and the groove.
  • Example 152 The access system of any one of Example 129 to Example 151 , wherein: the catheter assembly comprises a septum; and a distal tip of the reinforcement member is configured to be positioned proximal to the septum when the connector is attached to the catheter assembly.
  • Example 153 The access system of any one of Example 129 to Example 151 , wherein: the catheter assembly comprises a septum; the reinforcement member comprises a projection that extends distally from a surface of the connector; and at least a portion of the projection of the reinforcement member is configured to extend through the septum of the catheter assembly when the connector is attached to the catheter assembly.
  • Example 154 The access system of Example 153, wherein the septum comprises a sealable region that provides a fluid-tight seal prior to insertion of the projection of the reinforcement member through the sealable region.
  • Example 155 The access system of Example 153, wherein the septum comprises an opening that is in an unsealed state prior to insertion of the projection of the reinforcement member through the septum.
  • Example 156 The access system of Example 155, wherein the projection of the reinforcement member is configured to be inserted through the opening of the septum.
  • Example 157 The access system of any one of Example 153 to Example 156, wherein the projection extends distally past a distal end of the connector.
  • Example 158 The access system of any one of Example 153 to Example 156, wherein the projection is proximally recessed relative to a distal end of the connector.
  • Example 161 The access system of Example 159 or Example 160, wherein, when the connector is coupled with the catheter assembly, a distal tip of the reinforcement member is at or proximally spaced from a proximal surface of the valve.
  • Example 162 The access system of any one of Example 159 to Example 161 , wherein, when the connector is coupled with the catheter assembly, a portion of the reinforcement member extends through the septum.
  • Example 164 The access system of Example 163, wherein the sealable opening is substantially centered relative to the valve, and wherein, when the connector is coupled with the catheter assembly, the reinforcement member is substantially centered so as to be aligned with the sealable opening.
  • Example 166 The access system of any one of Example 159 to Example 165, wherein the removable piercing member further extends through the valve when extending through the septum and through the catheter tube.
  • Example 167 The access system of any one of Example 129 to Example 166, wherein the catheter assembly is a closed intravenous catheter system.
  • Example 168 The access system of Example 167, wherein the closed intravenous catheter system comprises an integrated side port through which fluid may be transferred to or from the catheter tube.
  • Example 169. The access system of any one of Example 129 to Example 166, wherein the catheter assembly Is an open Intravenous catheter system.
  • Example 170 The access system of any one of Example 129 to Example 169, further comprising a sealing member coupled to each of the reinforcement member and the support tube so as to form a fluid-tight seal to prevent ingress of fluid into or egress of fluid from a space between the reinforcement member and the support tube.
  • Example 171 The access system of Example 170, wherein the sealing member is fixedly secured to the reinforcement member and the support tube is movable relative to the sealing member.
  • Example 172 The access system of Example 170 or Example 171 , wherein the sealing member is attached to a proximal end of the reinforcement member.
  • Example 173 The access system of any one of Example 170 to Example 172 wherein the sealing member encompasses a proximal tip of the reinforcement member.
  • Example 174 The access system of any one of Example 129 to Example 173, further comprising the catheter assembly.
  • Example 175. A kit comprising: an access system according to any one of Example 129 to Example 174; and instructions for using the kit, the instructions comprising directions to: couple the connector to the catheter assembly while the catheter tube of the catheter assembly is positioned in the blood vessel of the patient; and advance the cannula from the retracted position to the advanced position.
  • Example 176 The kit of Example 175, wherein the instructions for using the kit further comprise directions to: couple a fluid transfer device to the cannula; and draw blood from the blood vessel through the cannula and into the fluid transfer device.
  • Example 177 A method of using the access system of any one of Example 129 to
  • Example 179 An access system comprising: a connector configured to couple with a closed intravenous catheter system that comprises a valve and a catheter tube that is configured to be positioned in a blood vessel of a patient; a reinforcement member coupled with the connector such that when the connector is coupled with the closed intravenous catheter system, no portion of the reinforcement member is in contact with the valve; and a cannula movable relative to the reinforcement member from a retracted position to an advanced position, wherein, when the connector and the closed intravenous catheter system are in a coupled state, at least a portion of the cannula is configured to be advanced through the valve and through at least a portion of the catheter tube as the cannula is transitioned from the retracted position to the advanced position.
  • Example 181 The access system of any one of Example 178 to Example 180, wherein the closed intravenous catheter system is configured to be preplaced in the patient such that the catheter tube is positioned in the blood vessel of the patient prior to coupling of the connector of the access system with the closed intravenous catheter system.
  • Example 182 The access system of any one of Example 178 to Example 181 , wherein, when the catheter tube of the closed intravenous catheter system is positioned in the blood vessel of the patient and when the connector of the access system and the closed intravenous catheter system are in the coupled state, advancement of the cannula to the advanced position enables fluid communication directly between the cannula and the blood vessel.
  • Example 183 The access system of any one of Example 178 to Example 182, wherein when the cannula is in the advanced position, a distal tip of the cannula extends distally past a distal tip of the catheter tube.
  • Example 185 The access system of any one of Example 178 to Example 184, wherein when the cannula is in the advanced position, at least a portion of the cannula is positioned outside of and distal to a distal tip of the reinforcement member.
  • Example 188 The access system of Example 187, wherein the support member is in a fixed relation relative to the flexible and/or polymeric tube so as to move in unison therewith.
  • Example 189 The access system of Example 187 or Example 188, wherein at least a distal end of the support member is encompassed by the reinforcement member when the cannula is in the retracted position.
  • Example 190 The access system of any one of Example 187 to Example 189, wherein at least an intermediate portion of the flexible and/or polymeric tube that continuously extends along at least a portion of each of the first and second segments is encompassed by one or more of the reinforcement member and the support member along a full length of the intermediate portion.
  • Example 192 The access system of any one of Example 187 to Example 191 , wherein a distal tip of the support member corresponds with a distal terminus of the second segment.
  • Example 193 The access system of any one of Example 187 to Example 192, wherein the flexible and/or polymeric tube fits snugly within the support member.
  • Example 194 The access system of any one of Example 187 to Example 193, wherein the support member is fixedly secured to the flexible and/or polymeric tube.
  • Example 195 The access system of Example 194, wherein the support member is adhered to the flexible and/or polymeric tube.
  • Example 196 The access system of any one of Example 187 to Example 195, wherein the flexible and/or polymeric tube extends through a full length of the support member.
  • Example 197 The access system of any one of Example 187 to Example 196, wherein the support member extends along a full length of the second segment.
  • Example 198 The access system of any one of Example 187 to Example 197, wherein: the cannula further comprises a third segment that extends proximally from the second segment; the third segment comprises a proximal tube having an outer diameter that is larger than an outer diameter of the flexible and/or polymeric tube; and the flexible and/or polymeric tube is fixedly secured to the proximal tube.
  • Example 200 The access system of Example 199, wherein the first segment is formed exclusively from the flexible and/or polymeric tube.
  • Example 201 The access system of Example 199, wherein the flexible and/or polymeric tube is formed of a unitary piece of material that extends continuously from the first segment to the second segment.
  • Example 202 The access system of any one of Example 187 to Example 201 , wherein the flexible and/or polymeric tube is formed of polyimide.
  • Example 203 The access system of any one of Example 187 to Example 202, wherein the support member comprises a support tube that circumscribes an outer surface of the flexible and/or polymeric tube.
  • Example 206 The access system of any one of Example 187 to Example 205, wherein the reinforcement member defines a lumen that defines an inner diameter that is no greater than 20 percent larger than an outer diameter of the support member.
  • Example 207 The access system of any one of Example 187 to Example 206, wherein the support member prevents kinking of the flexible and/or polymeric tube when the first segment encounters force resistive to distal advancement of the distal tip of the cannula by preventing lateral movement of the flexible and/or polymeric tube within the support member in an amount that otherwise would be sufficient to kink the flexible and/or polymeric tube.
  • Example 208. The access system of Example 186, wherein the first segment comprises a first tube that comprises a first end face, the second segment comprises a second tube that comprises a second end face, and the first and second end faces abut one another at an interface positioned at the distal terminus of the second segment.
  • Example 209 The access system of Example 208, wherein each of the first and second end faces is transversely oriented relative to a longitudinal axis of the cannula.
  • Example 210 The access system of Example 208 or Example 209, wherein the second tube is formed of stainless steel.
  • Example 212 The access system of any one of Example 208 to Example 211 , further comprising a tie layer extending over the interface and at least a portion of each of the first and second tubes of the first and second segments, respectively, to attach the first and second tubes together or to reinforce an attachment between the first and second tubes.
  • Example 218 The access system of any one of Example 212 to Example 217, wherein a distal tip of the tie layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the tie layer is configured to contact an internal surface of the catheter tube to delimit proximal movement of the cannula relative to the catheter tube.
  • Example 223 The access system of any one of Example 178 to Example 222, wherein a distal tip of the cannula is positioned within the reinforcement member when the cannula is in the retracted position, such that the distal tip of the cannula is first positioned distal of and external to the reinforcement member only after the cannula has been moved from the retracted position.
  • Example 224 The access system of any one of Example 178 to Example 222, wherein a distal tip of the cannula is first positioned distal of and external to the reinforcement member when the cannula is in the retracted position.
  • Example 225 The access system of any one of Example 178 to Example 224, wherein the cannula comprises a first distal segment that is relatively softer than a second segment that is proximally adjacent to the first segment, and wherein the second segment comprises a distal terminus that is within the reinforcement member when the cannula is in the retracted position.
  • Example 226 The access system of any one of Example 178 to Example 225, wherein the distal terminus of the second segment of the cannula is within the reinforcement member when the cannula is in the advanced position.
  • Example 227 The access system of Example 225 or Example 226, wherein the distal terminus of the second segment of the cannula is within the reinforcement member throughout movement of the cannula from the retracted position to the advanced position.
  • Example 229. The access system of any one of Example 178 to Example 227, further comprising a sheath coupled to the connector, wherein the cannula extends through at least a portion of the sheath, the cannula being movable relative to the sheath from the retracted position to the advanced position.
  • Example 230 The access system of Example 229, wherein at least a portion of the sheath and at least a portion of the connector are integrally formed of a unitary piece of material.
  • Example 232 The access system of any one of Example 229 to Example 231 , wherein at least some portion of the cannula is positioned within the sheath throughout movement of the cannula from the retracted position to the advanced position.
  • Example 233 The access system of any one of Example 229 to Example 232, wherein the sheath comprises a tube having a proximal end and a distal end, and wherein the cannula extends through at least the proximal end of the sheath when in the retracted position and extends through at least the distal end of the sheath when in the advanced position.
  • Example 236 The access system of Example 234 or Example 235, wherein the follower and the sheath comprise a rotational alignment mechanism by which a rotational orientation of the cannula is maintained relative to the sheath.
  • Example 238 The access system of any one of Example 229 to Example 237, further comprising an actuator attached to the cannula, wherein at least a portion of the actuator is accessible external to the sheath so as to be manipulated to move the cannula between the advanced and retracted positions
  • Example 239. The access system of Example 238, wherein the sheath comprises a longitudinally extending track, and wherein a portion of the actuator extends through the track.
  • Example 240 The access system of any one of Example 229 to Example 239, wherein the cannula is devoid of an actuator.
  • Example 242 The access system of any one of Example 178 to Example 241 , wherein the connector comprises a snap-fit arrangement that is configured to snap onto a hub of the closed intravenous catheter system to securely couple the connector to the closed intravenous catheter system.
  • Example 243 The access system of Example 242, wherein the snap-fit arrangement comprises two or more flexible flaps that are configured to selectively attach to the hub of the closed intravenous catheter system.
  • Example 248 The access system of any one of Example 245 to Example 247, wherein the projection extends distally past a distal end of the connector.
  • Example 249. The access system of any one of Example 245 to Example 247, wherein the projection is proximally recessed relative to a distal end of the connector.
  • Example 250 The access system of any one of Example 178 to Example 249, wherein, when the connector is coupled with the closed intravenous catheter system, the reinforcement member aims the cannula toward a sealable opening of the valve such that the distal tip of the cannula is advanced through the sealable opening of the valve as the cannula is moved from the retracted position to the advanced position.
  • Example 253 The access system of any one of Example 178 to Example 252, wherein the closed intravenous catheter system comprises an Integrated side port through which fluid may be transferred to or from the catheter tube.
  • Example 256 The access system of any one of Example 178 to Example 255, wherein the closed intravenous catheter system comprises a hub that defines a cavity, and wherein the valve is positioned within the cavity.
  • Example 258 The access system of Example 257, wherein the septum defines a permanent opening and the valve defines a sealable opening that are aligned with a longitudinal axis that extends through the catheter tube.
  • Example 260 The access system of Example 258 or Example 259, wherein a distal tip of the cannula is advanced substantially rectilinearly through the septum, the valve, and into the catheter tube as the cannula is transitioned from the retracted position toward the advanced position.
  • Example 261. The access system of any one of Example 257 to Example 260, wherein the reinforcement member extends through the septum when the connector is coupled with the closed intravenous catheter system.
  • Example 262 The access system of any one of Example 178 to Example 261 , wherein the cannula comprises a first segment at a distal end thereof and a second segment that extends proximally from the first segment, wherein the second segment is stiffer than the first segment.
  • Example 263 The access system of Example 262, wherein at least a portion of the second segment extends through the valve when the cannula is in the advanced position.
  • Example 264 The access system of Example 262 or Example 263, wherein the second segment comprises a rigid tube that encompasses a flexible tube.
  • Example 265. The access system of Example 264, wherein the rigid tube is formed of a metallic material and wherein the flexible tube is formed of a polymeric material.
  • Example 266 The access system of any one of Example 178 to Example 265, further comprising the closed intravenous catheter system.
  • Example 267 A kit comprising: an access system according to any one of Example 178 to Example 266: and instructions for using the kit, the instructions comprising directions to: couple the connector to the closed intravenous catheter system while the catheter tube of the closed intravenous catheter system is positioned in the blood vessel of the patient; and advance the cannula from the retracted position to the advanced position.
  • Example 268 The kit of Example 267, wherein the instructions for using the kit further comprise directions to: couple a fluid transfer device to the cannula; and draw blood from the blood vessel through the cannula and into the fluid transfer device.
  • Example 269. A method of using the access system of any one of Example 178 to Example 266, the method comprising: coupling the connector to the closed intravenous catheter system while the catheter tube of the closed intravenous catheter system is positioned in the blood vessel of the patient; and advancing the cannula from the retracted position to the advanced position.
  • An access system comprising: a connector configured to couple with an implement port of a catheter assembly that is configured to transition from an insertion configuration to an access configuration, the catheter assembly comprising: a hub comprising the implement port, an access port, and a cavity, the implement port being configured to permit a piercing implement to extend therethrough when the catheter assembly is in the insertion configuration; a catheter tube coupled to the hub, the catheter tube defining a first lumen in fluid communication with the cavity, the first lumen being configured to receive at least a portion of the piercing implement therein when the catheter assembly is in the insertion configuration, the catheter tube being configured for insertion in a blood vessel of a patient; an extension tube coupled to the access port of the hub, the extension tube defining a second lumen in fluid communication with the cavity; and a valve coupled to the hub, the valve being configured to be in an open state when the piercing implement extends therethrough while the catheter assembly is in the insertion configuration, the valve further being configured to transition to a closed state to prevent fluid
  • Example 271 The access system of Example 270, wherein the cannula comprises a polymeric tube and a rigid support member that encompasses a portion of the polymeric tube, and wherein the support member is sized such that at least a portion of the support member passes through the reinforcement member as the cannula is moved to the advanced position.
  • Example 272 The access system of Example 270 or Example 271 , further comprising the catheter assembly.
  • Example 273 The access system of any one of Example 270 to Example 272, wherein the catheter assembly further comprises the piercing implement.
  • Example 274 The access system of any one of Example 270 to Example 273, wherein the piercing implement comprises a needle.
  • Example 275 An access system comprising: a connector configured to couple with a catheter assembly that comprises a catheter tube configured to be positioned in a blood vessel of a patient; a cannula movable relative to the connector from a retracted position to an intermediate position and from the intermediate position to an advanced position, the cannula comprising a distal tip; and a reinforcement tube that encompasses at least the distal tip of the cannula and is releasably connected to the cannula so as to move in tandem with the cannula throughout movement of the cannula from the retracted position to the Intermediate position, the reinforcement tube and the cannula being configured to disconnect from each other at the intermediate position to permit the cannula to advance distally through the reinforcement tube as the cannula is transitioned from the intermediate position to the advanced position.
  • Example 276 The access system of Example 275, wherein, when the connector and the catheter assembly are in a coupled state, at least the distal tip of the cannula is configured to be advanced through at least a portion of the catheter tube as the cannula is moved to the advanced position.
  • Example 277 The access system of Example 275 or Example 276, wherein the reinforcement tube becomes substantially stationary relative to the connector when the cannula passes through the intermediate position.
  • Example 278 The access system of Example 277, wherein the reinforcement tube remains substantially stationary relative to the connector as the cannula transitions from the intermediate position to the advanced position.
  • Example 279. The access system of any one of Example 275 to Example 278, further comprising an arm attached to the cannula and a catch attached to the reinforcing tube, wherein the arm engages the catch throughout movement of the cannula from the retracted position to the intermediate position and disengages from the catch as the cannula is moved distally past the intermediate position.
  • Example 280 The access system of Example 279, further comprising a sheath that comprises a first chamber defining a first diameter and a second chamber positioned distal of the first chamber and defining a second diameter larger than the first diameter, wherein the first chamber of the sheath is sized to constrain at least a distal end of the arm from flexing outwardly while positioned in the first chamber such that the arm engages the catch while in the first chamber, and wherein the second chamber of the sheath is sized to permit the distal end of the arm to flex outwardly to disengage from the catch and to move distally past the catch.
  • Example 281 The access system of Example 280, wherein a proximal end of the second chamber is proximal of the intermediate position.
  • Example 282 The access system of Example 280 or Example 281 , wherein the arm is outwardly biased such that the distal end of the arm automatically flexes outwardly and disengages from the catch when advanced through the second chamber of the sheath.
  • Example 283 The access system of Example 280 or Example 281 , wherein the arm and the catch comprise a ramped interface that causes the distal end of the arm to flex outwardly and disengage from the catch when positioned in the second chamber of the sheath and when the reinforcing tube encounters increased resistance to distal movement as the cannula is advanced toward the advanced position.
  • Example 284 An access system comprising: a connector configured to couple with a catheter assembly that includes a catheter tube preplaced into a blood vessel of a patient; and a cannula movable relative to the connector from a retracted state to a deployed state, the cannula comprising at least a distal portion that is configured to be advanced through at least a portion of the catheter tube as the cannula is transitioned from the retracted state to the advanced state, the cannula comprising: a first segment at a distal end of the cannula; a second segment attached to the first segment at an interface, the first segment being relatively softer than the second segment; and a tie layer extending over the interface and at least a portion of each of the first and second segments to attach the first and second segments together or to reinforce an attachment between the first and second segments.
  • Example 285. The access system of Example 284, wherein the second segment comprises a metal tube.
  • Example 286 The access system of Example 284 or Example 285, wherein a distal tip of the tie layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the tie layer is configured to contact an Internal surface of the catheter tube to delimit proximal movement of the cannula relative to the catheter tube.
  • Example 287 The access system of any one of Example 284 or Example 286, wherein a distal tip of the tie layer is proximally spaced from the distal tip of the cannula, and wherein the distal tip of the tie layer is configured to contact an internal surface of the catheter tube to provide tactile feedback to a user regarding a position of the cannula relative to the catheter tube.
  • Example 288 The access system of any one of Example 284 or Example 288, further comprising the catheter assembly.
  • Example 289. A method comprising: coupling an access system that comprises a reinforcement member and a movable cannula with a preplaced closed catheter system that comprises a valve and a catheter tube that is positioned within a blood vessel of a patient, said coupling comprising securing the access system to the preplaced closed catheter system such that at least one of the following conditions is satisfied: a distal tip of the reinforcement member is fixed at a position that is at a proximal end of the valve; the distal tip of the reinforcement member is fixed at a position that is proximally recessed from a proximal end of the valve; no portion of the reinforcement member is in contact with the valve; or no portion of the reinforcement member extends through the valve; and advancing the cannula of the access system from a position inside the reinforcement member through the valve of the closed catheter system and through at least a portion of the catheter tube.
  • Example 290 The method of Example 289, wherein the closed catheter system comprises a valve assembly that includes the valve and further includes a septum positioned proximal to the valve.
  • Example 291 The method of Example 290, wherein said coupling comprises advancing the distal tip of the reinforcement member of the access system through the septum before the distal tip is fixed at the position that is at or proximally recessed from a proximal end of the valve.
  • Example 292 The method of any one of Example 289 to Example 291 , wherein the reinforcement member comprises a tube.
  • Example 29 The method of any one of Example 289 to Example 292, wherein said coupling is achieved without making any contact between the reinforcement member and the valve.
  • Example 294 The method of any one of Example 289 to Example 293, wherein said coupling is achieved without advancing any portion of the reinforcement member into or through the valve.
  • Example 295. The method of any one of Example 289 to Example 294, wherein the valve of the closed catheter system comprises a closable opening that is configured to permit a piercing element to extend therethrough during insertion of the catheter tube into the blood vessel of the patient, wherein the sealable region is in a selfsealed state with the piercing element having been removed therefrom during said coupling, and wherein said advancing the cannula comprises advancing the cannula through the closable opening of the valve.
  • Example 296 The method of any one of Example 289 to Example 295, wherein said advancing the cannula is achieved without advancing the distal tip of the reinforcement member distally past the proximal end of the valve.
  • Example 297 The method of any one of Example 289 to Example 296, wherein said advancing the cannula is achieved without contacting the reinforcement member to the valve.
  • Example 298 The method of any one of Example 289 to Example 297, wherein said advancing the cannula is achieved without extending the reinforcement member through any portion of the valve.
  • Example 299. The method of any one of Example 289 to Example 298, wherein the closed catheter system further comprises a hub coupled with the catheter tube at a first port of the hub, wherein an extension tube is coupled with a second port of the hub, and wherein a third port of the hub comprises the valve.
  • Example 300 The method of Example 299, wherein said coupling the access system with the preplaced closed catheter system comprises coupling a connector of the access system with the third port of the hub.
  • Example 301 The method of Example 299 or Example 300, wherein said advancing the cannula comprises advancing a distal portion of the cannula through the third port of the hub then through the first port of the hub and into the catheter tube.
  • Example 302. The method of any one of Example 299 to Example 301 , wherein the hub of the preplaced closed catheter system is secured directly to the skin of the patient.
  • Example 303 The method of Example 302, wherein said coupling and said advancing are achieved without moving the hub of the preplaced catheter system relative to the skin of the patient.
  • Example 304 The method of Example 302 or Example 303, wherein the hub of the preplaced closed catheter system is positioned flat against the skin of the patient without any other element (e.g., wedge-shaped or otherwise) being present between the hub and the skin of the patient.
  • any other element e.g., wedge-shaped or otherwise
  • Example 305 The method of any one of Example 302 to Example 304, wherein a portion of the catheter tube is positioned within an insertion site that extends through the skin of the patient, and wherein said coupling and said advancing are achieved without contacting an external surface of one or more of the hub or the catheter tube to adjust a position of the portion of the catheter tube that extends through the insertion site.
  • Example 306 The method of any one of Example 289 to Example 305, wherein the access system further comprises an additional connector at a proximal end of the cannula, and wherein the method further comprises: coupling a fluid collection device to the additional connector; and after said advancing the cannula of the access system, drawing blood through the cannula into the fluid collection device.
  • Example 307 The method of Example 306, further comprising, after said drawing blood, retracting the cannula of the access system from the catheter tube.
  • Example 308 The method of Example 307, further comprising, after said retracting the cannula, decoupling the access system from the preplaced closed catheter system.
  • Example 309 The method of Example 307 or Example 308, further comprising, after said retracting the cannula, power injecting fluid into the patient via the preplaced closed catheter system.
  • Example 310 The method of any one of Example 289 to Example 309, wherein the catheter tube of the preplaced closed catheter system is inserted into a vein of the patient at any one of a dorsal arch of a hand, a forearm, or an antecubital fossa position.
  • Example 311 An access system comprising: a connector configured to couple with a catheter assembly that includes a catheter tube preplaced into a blood vessel of a patient; a reinforcement tube fixedly secured to the connector; and a cannula movable relative to the connector from a retracted state to a deployed state, the cannula comprising: a distal segment that comprises at least a portion of a flexible and/or polymeric tube; and a medial segment that extends proximally from the distal segment, the medial segment comprising a metal tube sized to pass through the reinforcement tube, wherein, when the cannula is in the retracted state, a distal tip of the medial segment is positioned within the reinforcement tube.
  • Example 312 The access system of Example 311 , wherein the reinforcement tube is metallic.
  • Example 313. The access system of Example 312, wherein the reinforcement tube comprises stainless steel.
  • Example 314 The access system of any one of Example 311 to Example 313, wherein at least a portion of the metal tube of the medial segment is positioned within the reinforcement tube throughout movement of the cannula from the retracted state to the deployed state.
  • Example 315 The access system of any one of Example 311 to Example 314, wherein a portion of the metal tube of the medial segment extends distally beyond a distal tip of the reinforcement tube when the cannula is in the deployed state.
  • Example 316 The access system of any one of Example 311 to Example 315, wherein the flexible and/or polymeric tube of the distal segment comprises at least one of polyimide, polyamide, PEEK, and polyurethane.
  • Example 317 The access system of any one of Example 311 to Example 316, wherein the distal segment is configured to extend through the catheter tube such that at least a distal end of the distal segment extends distally beyond a distal tip of the catheter tube when the cannula is in the deployed state.
  • Example 318 The access system of any one of Example 311 to Example 317, wherein the metal tube of the medial segment and the flexible and/or polymeric tube of the distal segment are joined together via heat shrink tubing.
  • Example 319 The access system of any one of Example 311 to Example 317, wherein the flexible and/or polymeric tube is longer than the first segment of the cannula, wherein the distal segment comprises a first portion of the flexible and/or polymeric tube, and wherein the medial segment comprises a second portion of the flexible and/or polymeric tube that extends continuously and proximally from the first portion of the flexible and/or polymeric tube.
  • Example 320 The access system of Example 319, wherein the metal tube of the medial segment encompasses the second portion of the flexible and/or polymeric tube.
  • Example 321 The access system of Example 320, wherein the metal tube of the medial segment comprises an inner tubular surface that approximates an outer tubular surface of the second portion of the flexible and/or polymeric tube to thereby support the second portion of the flexible and/or polymeric tube.
  • Example 322 The access system of Example 320 or Example 321 , wherein the metal tube of the medial segment prevents one or more of bending, buckling, or kinking of the second portion of the flexible and/or polymeric tube when the flexible and/or polymeric tube encounters proximally directed resistive forces as the cannula is advanced from the retracted state to the deployed state.
  • Coupled to can mean connected to in any suitable fashion, whether that coupling is direct or indirect.
  • Separate components may be coupled to each other.
  • separately identified components are integrally formed from a unitary piece of material, or stated otherwise, are included together in a monolithic element, those elements may also be said to be coupled to one another.
  • claim 3 can depend from either of claims 1 and 2, with these separate dependencies yielding two distinct embodiments; claim 4 can depend from any one of claims 1 , 2, or 3, with these separate dependencies yielding three distinct embodiments; claim 5 can depend from any one of claims 1 , 2, 3, or 4, with these separate dependencies yielding four distinct embodiments; and so on,

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Abstract

L'invention concerne un système d'accès pouvant comprendre un connecteur destiné à être couplé à un ensemble cathéter ayant un tube de cathéter qui peut être positionné dans un vaisseau sanguin d'un patient, un élément de renforcement fixé de manière fixe au connecteur, et une canule mobile par rapport à l'élément de renforcement à partir d'une position rétractée dans laquelle au moins une partie de la canule se trouve à l'intérieur de l'élément de renforcement vers une position avancée. La canule peut comprendre un tube polymère et un tube de support qui englobe une partie du tube polymère. Le tube de support définit un bord distal qui se trouve à l'intérieur de l'élément de renforcement lorsque la pointe distale du tube polymère est d'abord positionnée de manière distale et externe à l'élément de renforcement lorsque la canule passe de la position rétractée à la position avancée.
EP21899151.1A 2020-11-26 2021-11-26 Dispositifs, systèmes et procédés de prélèvement sanguin Pending EP4251047A4 (fr)

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CA3197752A1 (fr) 2020-11-26 2022-06-02 Avia Vascular, Llc Dispositifs, systemes et procedes de prelevement sanguin
US20240016428A1 (en) * 2022-07-14 2024-01-18 Becton, Dickinson And Company Integrated Catheter System with Near Patient Access Port and Visual Indicators
WO2024015551A1 (fr) * 2022-07-15 2024-01-18 Becton, Dickinson And Company Connecteur de prélèvement sanguin pour système d'accès vasculaire
WO2024141574A1 (fr) * 2022-12-29 2024-07-04 B. Braun Melsungen Ag Dispositif de transfert de fluide à travers un cathéter placé

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US11638806B2 (en) 2023-05-02
US20220176079A1 (en) 2022-06-09
US20220305238A1 (en) 2022-09-29
US20220313959A1 (en) 2022-10-06
MX2023006170A (es) 2023-06-08
US11389624B2 (en) 2022-07-19

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